Modular intraocular lens designs and methods

Abstract

To provide a method that allows for correction or modification of the optical result using a secondary lens that can be attached to a primary lens without the need to manipulate an IOL system and a lens capsule.SOLUTION: Provided is an intraocular lens system for implantation into a lens capsule having a capsulorhexis with a perimeter, comprising an intraocular primary component and an intraocular secondary component, the primary component being configured to releasably receive and connect to the secondary component to provide optical correction. The intraocular primary component has a body and one or more haptics, the primary component being configured to fit within the lens capsule, and the body having an equatorial perimeter greater than or equal to the perimeter of the capsulorhexis. The intraocular secondary component has an optical body with an equatorial perimeter less than the perimeter of the capsulorhexis.SELECTED DRAWING: Figure 2A

Description

[Technical field]

[0001] The present disclosure relates generally to intraocular lens (IOL) embodiments. In particular, the present disclosure relates to modular IOL design and method embodiments. [Background technology]

[0002] The human eye functions to provide vision by transmitting light through a clear outer portion called the cornea and focusing an image onto the retina by means of a crystalline lens. The quality of the image depends on many factors, including the size and shape of the eye and the transparency of the cornea and lens.

[0003] When the lens becomes less transparent (e.g., opacified) due to age or disease, vision is impaired due to a reduction in the light that can be transmitted to the retina. This insufficiency of the eye's lens is medically known as a cataract. The established treatment for this condition is to surgically remove the lens from the capsule and place an artificial intraocular lens (IOL) in the capsule. In the United States, the majority of cataractous lenses are removed by a surgical procedure called phacoemulsification. During this procedure, an opening (capsulotomy) is made in the anterior part of the capsule and a thin phacoemulsification cutting tip is inserted into the affected lens and vibrates ultrasonically. The vibrating cutting tip liquefies or emulsifies the lens so that it can be aspirated from the capsule. Once removed, the affected lens is replaced with an IOL.

[0004] After cataract surgery to implant an IOL, the optical result may be less than optimal or may require adjustment over time. For example, shortly after the procedure, it may be determined that the refractive correction is incorrect, leading to what is sometimes called a "refractive surprise." Also, for example, long after the procedure, it may be determined that the patient needs or desires a different correction, such as a stronger refractive correction, an astigmatism correction, or a multifocal correction.

[0005] In each of these cases, surgeons may be hesitant to remove the suboptimal IOL from the capsule and replace it with a new IOL. Generally, manipulation of the capsule to remove the IOL carries the risk of capsule damage, including subsequent rupture. This risk increases over time as the capsule collapses around the IOL and tissue ingrowth surrounds the haptics of the IOL. It is therefore desirable to be able to correct or change the optical outcome without having to remove the IOL or manipulate the capsule.

[0006] Various accessory lenses have been proposed to address the aforementioned shortcomings. For example, one possible solution involves an accessory lens that is in front of the capsule with haptics engaged in the ciliary sulcus. While this design may have the advantage of avoiding manipulation of the capsule, its main shortcoming is engagement in the ciliary sulcus. The ciliary sulcus is made of soft, vascularized tissue that is prone to damage when engaged by haptics or other materials. Such damage can lead to complications such as bleeding, inflammation, and hyphema. Thus, it would generally be desirable to avoid placing an accessory lens in the ciliary sulcus to avoid potential complications.

[0007] Another potential solution may include a lens system that avoids potential issues associated with the ciliary sulcus. The lens system may include a primary lens and a secondary lens. The secondary lens may be attached to the primary lens, both within the capsule. The primary lens may have a recess into which an edge of the secondary lens may be inserted for attachment. The recess is preferably radially outside of an opening (capsulorhexis) in the capsule to avoid interference with light transmission. To attach the secondary lens in-situ, the capsule must be manipulated around the periphery of the capsulorhexis to gain access to the recess of the primary lens. As previously mentioned, manipulation of the capsule may be undesirable given the risks associated therewith. Thus, although such lens systems may avoid potential damage to the ciliary sulcus by implanting both the primary and secondary lenses within the capsule, these systems do not avoid manipulation of the capsule to attach the secondary lens. Summary of the Invention [Problem to be solved by the invention]

[0008] Thus, a need remains for an IOL system and method that allows for correction or alteration of the optical result using a secondary lens that can be attached to the primary lens without the need to manipulate the capsular bag. [Means for solving the problem]

[0009] An embodiment of the present disclosure provides a modular IOL system including an intraocular primary component and a secondary component that, when combined, form an intraocular optical correction device. The primary component may include an intraocular base and the secondary component may include an intraocular lens. The base is configured to removably receive the intraocular lens. In some embodiments, the base may be configured as a lens, in which case the modular IOL system may be described as including a primary lens and a secondary lens. The primary component (e.g., base or primary lens) may be placed in the capsular bag using traditional cataract surgery techniques. The primary component may have a diameter larger than the diameter of the capsular incision to retain the primary component in the capsular bag. The secondary component (e.g., secondary lens) may have a diameter smaller than the diameter of the capsular incision so that the secondary component may be attached to the primary component without manipulation of the capsular bag. The secondary component may also be manipulated intraoperatively or postoperatively to correct or change the optical result without the need to remove the primary component and without the need to manipulate the capsular bag. For example, sub-components may be removed, rearranged and / or replaced to correct, modify and / or fine-tune the optical result.

[0010] Common indications for replacement of secondary components may be residual refractive error (e.g., in monofocal lenses), decentration error due to postoperative healing (e.g., in multifocal lenses), surgically induced astigmatic error (e.g., in toric lenses), changes in optical correction needs due to progressive disease, changes in optical correction requirements due to lifestyle changes, injury, age, etc.

[0011] The primary component may have haptics (e.g., protuberances) extending therefrom for centering within the capsular bag, and the secondary component may exclude haptics and instead rely on attachments on the primary component for stability. Such attachments may be radially inward of the periphery of the capsulotomy as well as radially outward of the field of view to avoid interference with light transmission. Alternatively or in addition, the attachments may include a small portion (e.g., less than 20%) of the periphery of the secondary component to minimize the possibility of interference with light transmission.

[0012] The primary component may have an anterior surface in intimate contact with a posterior surface of the secondary component to prevent ingress of bodily fluids, tissue ingrowth, and / or optical interference. The secondary component may be removably secured to the primary component by, for example, mechanical attachment and / or chemical attraction. Mechanical attachment may be facilitated by corresponding mating or interlocking structures on the primary and secondary components, respectively. Such structures may be preformed, for example, by molding or cutting, or formed in situ, for example, by laser etching. Chemical attraction may be facilitated by using similar materials with smooth surface finishes that have been activated, for example, by surface treatment. In some cases, it may be desirable to reduce chemical attraction and rely more on mechanical attachment for stability. In this case, the primary and secondary components may be formed of different materials or have adjacent surfaces that do not otherwise have chemical attraction.

[0013] Modular IOL systems and methods according to embodiments of the present disclosure may be applied to a variety of IOL types, including fixed monofocal, multifocal, toric, accommodative, and combinations thereof. In addition, modular IOL systems and methods according to embodiments of the present disclosure may be used to treat, for example, cataracts, large optical errors in myopic (near-sighted), hyperopic (far-sighted) and astigmatic eyes, ectopia vitreous, aphakia, pseudophakic eyes, and nuclear sclerosis.

[0014] Various other aspects of the embodiments of the present disclosure are described in the following detailed description and the drawings. The drawings illustrate example embodiments of the present disclosure, are not drawn to scale, include similar elements numbered the same, and may include dimensions (in millimeters) and angles (in degrees) by way of example, but not necessarily by way of limitation. [Brief description of the drawings]

[0015] [Figure 1] Schematic diagram of the human eye shown in cross-section. [Figure 2A]1 is a front cross-sectional view of a modular IOL placed within a capsular bag according to one embodiment of the present disclosure. [Figure 2B] 1 is a side cross-sectional view of a modular IOL placed within a capsular bag according to one embodiment of the present disclosure. [Figure 3A] 1A-1C are front cross-sectional views illustrating a schematic of a method for implanting a modular IOL according to one embodiment of the present disclosure. [Figure 3B] 1A-1C are front cross-sectional views illustrating a schematic of a method for implanting a modular IOL according to one embodiment of the present disclosure. [Figure 3C] 1A-1C are front cross-sectional views illustrating a schematic of a method for implanting a modular IOL according to one embodiment of the present disclosure. [Figure 3D] 1A-1C are front cross-sectional views illustrating a schematic of a method for implanting a modular IOL according to one embodiment of the present disclosure. [Figure 4A] 1A-1C are side cross-sectional views illustrating a schematic of a method for implanting a modular IOL according to one embodiment of the present disclosure. [Figure 4B] 1A-1C are front cross-sectional views illustrating a schematic of a method for implanting a modular IOL according to one embodiment of the present disclosure. [Figure 4C] 1A-1C are front cross-sectional views illustrating a schematic of a method for implanting a modular IOL according to one embodiment of the present disclosure. [Figure 4D] 1A-1C are front cross-sectional views illustrating a schematic of a method for implanting a modular IOL according to one embodiment of the present disclosure. [Diagram 5] FIG. 1 is a front view of a modular IOL according to one embodiment of the present disclosure in which a subsurface attachment mechanism is provided for connection between a primary lens and a secondary lens. [Figure 6A] 6 is a cross-sectional view taken along line 6-6 in FIG. 5 showing two embodiments of a subsurface attachment mechanism. [Figure 6B] 6 is a cross-sectional view taken along line 6-6 in FIG. 5 showing two embodiments of a subsurface attachment mechanism. [Figure 7] FIG. 1 is a front view of a modular IOL according to one embodiment of the present disclosure in which an extended attachment mechanism is provided to connect the primary and secondary lenses. [Figure 8A]8A-8C are cross-sectional views taken along line 8-8 of FIG. 7 showing three embodiments of an expansion attachment mechanism. [Figure 8B] 8A-8C are cross-sectional views taken along line 8-8 of FIG. 7 showing three embodiments of an expansion attachment mechanism. [Figure 8C] 8A-8C are cross-sectional views taken along line 8-8 of FIG. 7 showing three embodiments of an expansion attachment mechanism. [Figure 9A] FIG. 13 is a front view showing various positions of the mounting mechanism for adjusting the position of the secondary lens relative to the primary lens. [Figure 9B] FIG. 13 is a front view showing various positions of the mounting mechanism for adjusting the position of the secondary lens relative to the primary lens. [Figure 9C] FIG. 13 is a front view showing various positions of the mounting mechanism for adjusting the position of the secondary lens relative to the primary lens. [Figure 9D] FIG. 13 is a front view showing various positions of the mounting mechanism for adjusting the position of the secondary lens relative to the primary lens. [Figure 10] FIG. 1 is a front view of a modular IOL according to one embodiment of the present disclosure in which an etched subsurface attachment feature is provided for connection between the primary and secondary lenses. [Figure 11A] 11A-11C are cross-sectional views of the modular IOL shown in FIG. 10 illustrating various embodiments of etched subsurface attachment features. [Figure 11B] 11A-11C are cross-sectional views of the modular IOL shown in FIG. 10 illustrating various embodiments of etched subsurface attachment features. [Figure 11C] 11A-11C are cross-sectional views of the modular IOL shown in FIG. 10 illustrating various embodiments of etched subsurface attachment features. [Figure 11D] 11A-11C are cross-sectional views of the modular IOL shown in FIG. 10 illustrating various embodiments of etched subsurface attachment features. [Figure 11E] 11A-11C are cross-sectional views of the modular IOL shown in FIG. 10 illustrating various embodiments of etched subsurface attachment features. [Figure 11F] 11A-11C are cross-sectional views of the modular IOL shown in FIG. 10 illustrating various embodiments of etched subsurface attachment features. [Figure 12A]Schematic diagram of a front view of an alternative modular IOL according to one embodiment of the present disclosure. [Figure 12B] Schematic diagram of a cross-sectional view of an alternative modular IOL according to one embodiment of the present disclosure. [Figure 12C] 1 is a schematic diagram of a detailed view of an alternative modular IOL according to an embodiment of the present disclosure. [Figure 13A] Representative photomicrograph at 4X magnification of grooves (see arrows) formed by laser etching. [Figure 13B] Representative photomicrograph at 40X magnification of grooves (see arrows) formed by laser etching. [Figure 14] 1A-1D are various views of an alternative modular IOL according to an embodiment of the present disclosure. [Figure 14A] 15 is a cross-sectional view taken along line AA in FIG. 14. [Figure 14B] 15 is a cross-sectional view taken along line BB in FIG. 14. [Figure 14C] Detail of circle C in FIG. 14B. [Figure 15] 1A-1D are various views of an alternative modular IOL according to an embodiment of the present disclosure. [Figure 15A] 16 is a cross-sectional view taken along line AA in FIG. 15. [Figure 15B] 16 is a cross-sectional view taken along line BB in FIG. 15. [Figure 15C] Detail of circle C in FIG. 15B. [Figure 15D] FIG. 15C is an alternative detail view of circle C in FIG. 15B. [Figure 16] 1A-1D are various views of an alternative modular IOL according to an embodiment of the present disclosure. [Figure 16A] 17 is a cross-sectional view taken along line AA in FIG. 16. [Figure 16B] 17 is a cross-sectional view taken along line BB in FIG. 16. [Figure 16C] Detail of circle C in FIG. 16B. [Figure 16D] Detail of circle D in FIG. 16A. [Figure 17] 1A-1D are various views of an alternative modular IOL according to an embodiment of the present disclosure. [Figure 17A] 18 is a cross-sectional view taken along line AA in FIG. 17. [Figure 17B] Detail of circle B in FIG. 17A. [Figure 17C] Isometric view of assembled components. [Figure 18] 1A-1D are various views of an alternative modular IOL according to an embodiment of the present disclosure. [Figure 18A] 19 is a cross-sectional view taken along line AA in FIG. 18. [Figure 18B] Detail of circle B in FIG. 18A. [Figure 18C] Isometric view of assembled components. [Figure 19] 1A-1D are various views of an alternative modular IOL according to an embodiment of the present disclosure. [Figure 19A] 20 is a cross-sectional view taken along line AA in FIG. 19. [Figure 19B] Detail of circle B in FIG. 19A. [Figure 19C] Exploded view of components. [Figure 19D] Isometric assembly of components. [Figure 20] 1A-1D are various views of an alternative modular IOL according to an embodiment of the present disclosure. [Figure 20A] 21 is a cross-sectional view taken along line AA in FIG. 20. [Figure 20B] Detail of circle B in FIG. 20A. [Figure 20C] Exploded view of components. [Figure 20D] Isometric assembly of components. [Figure 20E] Side view of the lens. [Figure 20F] A rear view of the posterior surface of the lens. [Figure 20G] Detail of circle G in FIG. 20E. [Figure 20H] FIG. 2 is a front view of the anterior surface of the base. [Figure 20I] Detail of circle I in Figure 20H. [Figure 21] 1A-1D are various views of an alternative modular IOL according to an embodiment of the present disclosure. [Figure 21A] 22 is a cross-sectional view taken along line AA in FIG. 21. [Figure 21B] 22 is a cross-sectional view taken along line BB in FIG. 21. [Figure 21C] Detail of circle C in FIG. 21A. [Figure 21D] Detail of circle D in FIG. 21B. [Figure 21E] Isometric view of assembled components. [Figure 22] 1A-1D are various views of an alternative modular IOL according to an embodiment of the present disclosure. [Figure 22A] 23 is a cross-sectional view taken along line AA in FIG. 22. [Figure 22B] 23 is a cross-sectional view taken along line BB in FIG. 22. [Figure 22C] Detail of circle C in FIG. 22A. [Figure 22D] Detail of circle D in FIG. 22B. [Figure 23A] 1 is a schematic diagram of a lens removal system for a modular IOL according to one embodiment of the present disclosure. [Figure 23B] 1 is a schematic diagram of a lens removal system for a modular IOL according to one embodiment of the present disclosure. [Figure 23C] 1 is a schematic diagram of a lens removal system for a modular IOL according to one embodiment of the present disclosure. [Figure 23D] 1 is a schematic diagram of a lens removal system for a modular IOL according to one embodiment of the present disclosure. [Figure 24] FIG. 1 is a schematic flow chart of a method for using a modular IOL according to one embodiment of the present disclosure, where secondary lens exchange is motivated by suboptimal optical results detected intraoperatively. [Diagram 25] FIG. 1 is a schematic flow chart of a method for using a modular IOL according to one embodiment of the present disclosure, where secondary lens exchange is motivated by suboptimal optical results detected postoperatively. [Figure 26] 1 is a schematic flow chart of a method for using a modular IOL according to an embodiment of the present disclosure, in which a secondary lens is attached to a primary lens by forming an attachment means in situ. [Figure 27]1A-1D are various views of a further embodiment of a modular IOL according to the present disclosure. [Figure 27A] 28 is a cross-sectional view taken along line AA in FIG. 27. [Figure 27B] 28 is a cross-sectional view taken along line BB in FIG. 27. [Figure 27C] Detail of circle C in FIG. 27A. [Figure 27D] Detail of circle D in FIG. 27B. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] With reference to FIG. 1, a human eye 10 is shown in cross-section. The eye 10 has been described as a light-responsive organ for several purposes. As a conscious sense organ, the eye enables vision. Rod and cone cells in the retina 24 enable conscious light perception and vision, including color discrimination and depth perception. In addition, the human eye's non-image-forming photosensitive ganglion cells in the retina 24 receive light signals that affect the regulation of pupil size, the regulation and inhibition of the hormone melatonin, and the entrainment of the body clock.

[0017] The eye 10 is not strictly a sphere, but rather a fused two-piece unit. A smaller, more curved anterior unit called the cornea 12 is connected to a larger unit called the sclera 14. The corneal area 12 is usually about 8 mm (0.3 in) in radius. The sclera 14 contains the remaining 5 / 6ths and usually has a radius of about 12 mm. The cornea 12 and sclera 14 are connected by a ring called the limbus. The transparency of the cornea 12 allows the iris 16, which is the color of the eye, and its black center, the pupil, to be seen instead of the cornea 12. An ophthalmoscope is required to see inside the eye 10, as light is not reflected. The fundus (the area opposite the pupil), including the macula 28, shows the distinctive pale optic disc (papilla) through which the blood vessels entering the eye pass and through which the optic nerve fibers 18 exit the eye.

[0018] Thus, the eye 10 is three-layered, containing three transparent structures. The outermost layer is the cornea 12 and the sclera 14. The middle layer is the choroid 20, the ciliary body 22, and the iris 16. The innermost layer is the retina 24, which gets its circulation from the blood vessels of the choroid 20 and the retinal blood vessels. It can be seen through an ophthalmoscope. Within these layers are the aqueous humor, the vitreous body 26, and the soft lens 30. The aqueous humor is a clear fluid contained in two parts: the anterior chamber, between the cornea 12, the iris 16, and the exposed part of the lens 30, and the posterior chamber, between the iris 16 and the lens 30. The lens 30 is suspended from the ciliary body 22 by the ciliary corpuscles 32 (Zinn's corpuscles), which are made up of tiny, transparent fibers. The vitreous body 26 is a clear jelly that is much larger than the aqueous humor.

[0019] The crystalline lens 30 is a transparent, biconvex structure in the eye which, together with the cornea 12, refracts light that is directed to the retina 24. By changing its shape, the lens 30 functions to change the focal length of the eye so that it can focus on objects at different distances, thereby allowing a sharp, real image of an object to be formed on the retina 24. This adjustment of the lens 30 is known as accommodation, and is similar to the focusing of a photographic camera by the movement of its lens.

[0020] The lens has three main parts: the lens capsule, the lens epithelium, and the lens fibers. The lens capsule forms the outermost layer of the lens, and the lens fibers form most of the interior of the lens. The cells of the lens epithelium, which are between the lens capsule and the outermost layer of lens fibers, are found primarily on the anterior side of the lens, but extend posteriorly just past the equator.

[0021] The lens capsule is a smooth, transparent basement membrane that completely surrounds the lens. The capsule is elastic and composed of collagen. It is synthesized by the lens epithelium and its main components are type IV collagen and sulfated glycosaminoglycans (GAGs). The capsule is so elastic that it causes the lens to assume a more spherical shape when not under tension of the zonular fibers that connect it to the ciliary body 22. The thickness of the capsule varies from about 2 to 28 micrometers, being thickest near the equator and thinnest near the posterior pole. The lens capsule may have a higher curvature than the posterior part of the lens.

[0022] Various diseases and disorders of the crystalline lens 30 may be treated by the IOL. By way of example, and not necessarily by way of limitation, modular IOLs according to embodiments of the present disclosure may be used to treat cataracts, large optical errors in myopic (near-sighted), hyperopic (far-sighted) and astigmatic eyes, ectopia vitreous, aphakia, pseudophakic eyes, and nuclear sclerosis. For purposes of illustration, however, modular IOL embodiments of the present disclosure will be described with respect to cataracts.

[0023] The following detailed description describes various embodiments of a modular IOL system including primary and secondary intraocular components, i.e., an intraocular base configured to removably receive an intraocular lens. In some embodiments, the base may be configured to provide optical correction, in which case the modular IOL system may be described as including a primary lens and a secondary lens. Principles and features described with reference to embodiments in which the base is configured for optical correction may be applied to embodiments in which the base is not configured for optical correction, and vice versa. More broadly, features described with reference to any one embodiment may be applied to and incorporated in other embodiments.

[0024] 2A and 2B, a modular IOL system 50 / 60 is shown implanted within the capsule 34 of a lens 30 having a capsulotomy 36. The modular IOL system may include a primary lens 50 and a secondary lens 60. The primary lens 50 may include a body portion 52, a pair of haptics 54 for fixing and centering the primary lens 50 within the capsule 34, and means for attachment to the secondary lens 60 (not shown here but described below). The secondary lens 60 may include an optic body portion 62 and corresponding means for attachment to the primary lens 50 (not shown here but described below), but may not include haptics. The anterior surface of the body portion 52 of the primary lens 50 may be in intimate contact with the posterior surface of the body portion 62 of the secondary lens 60 without any intervening material (e.g., adhesive, aqueous humor, tissue ingrowth, etc.) therebetween. For example, the anterior surface of the body portion 52 may be in direct contact with the posterior surface of the body portion 62. While the primary lens 50 remains within the capsular bag 34 of the lens 30, the secondary lens 60 may be removably attached to the primary lens 50 on both an acute and chronic basis to facilitate replacement of the secondary lens 60.

[0025] The body 52 of the primary lens 50 may provide some refractive correction, but less than that required for optimal optical results. The optimal optical result may be provided by a combination of the corrections provided by the optical body 52 of the primary lens 50 along with the optical body 62 of the secondary lens 60. For example, the optical body 62 of the secondary lens 60 may change (e.g., add or subtract) optical power (for single vision correction), toric function (for astigmatism correction), and / or diffractive function (for multifocal correction).

[0026] The secondary lens 60 may have an outer diameter d1, the capsulotomy 36 may have an inner diameter d2, and the body 52 of the primary lens 50 may have an outer diameter d3, where d1 < d2 ≦ d3. This arrangement provides a gap between the secondary lens 60 and the periphery of the capsulotomy 36 such that the secondary lens 60 can be attached to and removed from the primary lens 50 without touching or disturbing any part of the lens capsule 34. By way of non-limiting example, assuming the capsulotomy has a diameter of about 5 - 6 mm, the body of the primary lens (i.e., excluding the support portion) may have a diameter of about 5 - 8 mm, and the secondary lens may have a diameter of less than about 3 - 5 mm, thereby providing a radial gap of about 1.5 mm or less between the secondary lens and the periphery of the capsulotomy. Regardless of this example, any suitable dimensions may be selected to provide a gap between the secondary lens and the periphery of the capsulotomy to reduce the need to manipulate the lens capsule in attaching the secondary lens to the primary lens.

[0027] With reference to Figures 3A-3D (front views) and Figures 4A-4D (side cross-sectional views), a method for implanting the modular IOL system 50 / 60 is illustrated diagrammatically. As seen in Figures 3A and 4A, the cataractous lens 30 includes an opaque or cloudy central portion 38 within the capsular bag 34. Access to the lens 30 for cataract surgery may be provided by one or more lateral incisions in the cornea. A capsulotomy (circular hole) 36 may be formed in the anterior capsular bag 34 using a manual tool or a femtosecond laser. As seen in Figures 3B and 4B, the opaque central portion 38 is removed by phacoemulsification and / or aspiration through the capsulotomy 36. The primary lens 50 is delivered in a rolled form using a tube that is inserted into the capsular bag 34 through the capsulotomy 36. The primary lens 50 is removed from the delivery tube and allowed to unfold. With gentle manipulation, the haptics 54 of the primary lens engage the inner equator of the lens capsule 34, centrally positioning the lens body 52 relative to the capsulorhexis 36, as seen in FIGS. 3C and 4C. The secondary lens 60 is delivered in a rolled form using a tube, with its distal tip positioned adjacent to the primary lens 50. The secondary lens 60 is removed from the delivery tube and allowed to unfold. With gentle manipulation, the secondary lens 60 is centrally positioned relative to the capsulorhexis 36. Without manipulating the lens capsule 34 or the primary lens 50, the secondary lens 60 is then attached to the primary lens 50, as seen in FIGS. 3D and 4D. If necessary, the secondary lens 60 may be removed and / or replaced in a similar manner by reversing the steps as appropriate. Alternatively, the primary lens 50 and secondary lens 60 may be implanted as a unit, thus eliminating the delivery step.

[0028] Since it may be difficult to determine which side of the secondary lens 60 should face the primary lens 50, the secondary lens may include markings to indicate the appropriate position. For example, a clockwise arrow may be positioned along the perimeter of the front surface of the secondary lens 60, appearing as a clockwise arrow when the correct side is positioned up and as a counterclockwise arrow when the incorrect side is positioned up. Alternatively, a two-layered color marking may be positioned along the perimeter of the front surface of the secondary lens 60, appearing as a first color when the correct side is positioned up and as a second color when the incorrect side is positioned down. Other positional indicator markings may be used on the secondary lens 60, and a similar marking scheme may be applied to the primary lens 50.

[0029] With reference to FIG. 5, a subsurface attachment mechanism 70 may be used to removably secure the secondary lens 60 to the primary lens 50. The attachment mechanism 70 may be located radially inward of the periphery of the capsulotomy 36 and radially outward of the field of view to avoid interference with light transmission. Alternatively or in addition, the attachment mechanism 70 may have radial and lateral extent limited to a small percentage (e.g., less than 10-20%) of the circumference of the secondary lens 50 to minimize the possibility of interference with light transmission. Although two diametrically opposed attachment mechanisms 70 are shown, any suitable number, evenly or unevenly distributed around the circumference of the secondary lens 60, may be used.

[0030] If the primary and secondary lenses 50 and 60 are delivered simultaneously, it may be desirable to align the attachment mechanism 70 with a roll axis 80 about which the lenses 50 and 60 may be rolled for insertion by a delivery tool. Because the secondary lens 60 may move relative to the primary lens 50 as it is rolled about the axis 80, providing the attachment mechanism 70 along the roll axis 80 minimizes stress on the attachment mechanism 70. Thus, the attachment mechanism 70 may be coaxially aligned with the roll axis 80 and configured to extend a limited distance from the axis 80 (e.g., less than 10-20% of the circumference of the secondary lens 60).

[0031] The attachment mechanism 70 may be configured to have a mating or interlocking structure, as shown in Figures 6A and 6B. In general, the structure includes a male portion and a female portion that are removably connectable. The female portion is configured to receive the male portion and limits relative motion in at least two dimensions (e.g., up-down and left-right) between the primary lens 50 and the secondary lens 60. The female portion and the male portion may be configured to have an interlocking structure such that relative motion in three dimensions (e.g., up-down, left-right, front-back) between the primary lens 50 and the secondary lens 60 is limited. The attachment mechanism 70 may be engaged and disengaged by application of orthogonal forces in the rear (push) and front (pull) directions, respectively. The attachment mechanism 70 may be preformed, for example, by molding, cutting, etching, or a combination thereof.

[0032] In the example shown, each attachment mechanism 70 includes a mating cylindrical projection 72 and a cylindrical recess or groove 74. Other mating or interlocking structures may also be used. The cylindrical structures shown have the advantage of allowing slight rotation of the secondary lens 60 relative to the primary lens 50 when rolled for delivery, thus further reducing stress thereon. As shown in FIG. 6A, the cylindrical projection 72 may extend forward from the anterior surface of the body 52 of the primary lens 50, and the cylindrical recess 74 may extend forward into the posterior surface of the body 62 of the secondary lens 60 near its radial peripheral region. Alternatively, as shown in FIG. 6B, the cylindrical projection 72 may extend rearward from the posterior surface of the body 62 of the secondary lens 60 near its radial peripheral region, and the cylindrical recess 74 may extend rearward into the anterior surface of the body 52 of the primary lens 50. The configuration shown in FIG. 6B may be particularly suitable where the primary lens 50 is a pre-existing, implanted IOL in which a recess 74 may be etched in situ, for example by a laser.

[0033] With reference to FIG. 7, an extension attachment mechanism 90 may be used to releasably couple the primary lens 50 and the secondary lens 60. The extension attachment mechanism 90 may be similar to the subsurface attachment mechanism 70 except as shown and described. The extension attachment mechanisms 90 may extend radially from the periphery of the secondary lens 60, each including a mating or interlocking structure. Examples are shown in FIGS. 8A-8C. In FIG. 8A, a cylindrical portion 92 extends from the outer edge of the secondary lens 60, and a cylindrical recess 94 extends from the outer edge of the primary lens 50. In FIG. 8B, a system is shown in which a cylindrical portion 92 extends from the outer edge of the primary lens 50, and a cylindrical recess 94 extends from the outer edge of the secondary lens 60. In both the embodiments shown in FIG. 8A and FIG. 8B, the attachment mechanism 90 may be engaged and disengaged by application of orthogonal forces in the rearward (push) and forward (pull) directions, respectively. Alternatively, in the embodiment shown in Figure 8C, the attachment mechanisms 90 may be engaged and disengaged by applying a rotational force in a clockwise or counterclockwise direction, depending on which lens 50 / 60 is attached to the cylindrical portion 92 and cylindrical recess 94, respectively. Additionally, while the embodiment of Figure 7 only illustrates the use of two attachment mechanisms 90, any suitable number of attachment mechanisms 90 may be utilized within the principles of the present disclosure.

[0034] With reference to Figures 9A-9D, the portion of the attachment mechanism 90 associated with the secondary lens 60 may be positioned such that the center of the secondary lens 60 is aligned with the center of the primary lens 50. Alternatively, to accommodate misalignment of the primary lens 50 due to uneven post-operative healing, for example, the portion of the attachment mechanism 90 associated with the secondary lens 60 may be offset as shown in Figures 9B-9D. In Figure 9B, the portion of the attachment mechanism 90 associated with the secondary lens 60 is rotationally offset. In Figure 9C, the portion of the attachment mechanism 90 associated with the secondary lens 60 is offset upward. In Figure 9D, the portion of the attachment mechanism 90 associated with the secondary lens 60 is offset laterally. Anterior-posterior offsets may also be used, as described in more detail with reference to Figures 11C and 11F. Each of the embodiments shown in Figures 9B, 9C, 9D, 11C, and 11F are provided as examples, and offsets may be made in various magnitudes depending on the misalignment of the primary lens 50 in any direction (front, posterior, up, down, right, left, clockwise, counterclockwise) or combinations thereof. Additionally, although attachment mechanism 90 is shown as an example, the same principles may be applied to the other attachment means described herein.

[0035] With reference to FIG. 10, an alternative subsurface attachment mechanism 100 may be used to removably couple the secondary lens 50 to the primary lens 60. The subsurface attachment mechanism 100 may be similar to the subsurface attachment mechanism 70 except as shown and described. The subsurface attachment mechanism 100 may include a mating or interlocking structure that extends along an arcuate path near the peripheral edge of the secondary lens 60. The subsurface attachment mechanism 100 may include a protrusion 102 and a corresponding recess or groove 104 into which the protrusion 102 may be received. The protrusion 102 may extend from the rear surface of the secondary lens 60 and the corresponding recess or groove 104 may extend into the front surface of the primary lens 50 as shown in FIG. 11A (separated) and FIG. 11D (attached). Alternatively, the protrusion 102 may extend from the anterior surface of the primary lens 50, and a corresponding recess or groove 104 may extend into the posterior surface of the secondary lens 60, as shown in FIG. 11B (separated) and FIG. 11E (attached). In either embodiment, the anterior-posterior dimension of the protrusion 102 may match a recess or groove 104 of the same size to provide intimate contact between the anterior surface of the primary lens 50 and the posterior surface of the secondary lens 60. Alternatively, the anterior-posterior dimension of the protrusion 102 may exceed a recess or groove 104 of the same size to provide an anterior-posterior offset, as shown in FIG. 11C (separated) and FIG. 11F (attached). Moreover, one of ordinary skill in the art will readily appreciate that any suitable number of attachment mechanisms 100 may be utilized within the principles of the present disclosure.

[0036] With reference to FIG. 12A, an alternative subsurface attachment mechanism 105 may be used to couple the secondary lens 60 to the primary lens 50. The subsurface attachment mechanism 105 may be similar to the subsurface attachment mechanism 100 except as shown and described. As seen in FIG. 12B, which is a cross-sectional view taken along line BB in FIG. 12A, the subsurface attachment mechanism 105 may include a mating or interlocking structure including a protrusion 107 and a series of holes 109 that may receive the protrusion 107. The holes 109 may be distributed in a pattern as seen in FIG. 12C, which shows some alternative details of box C in FIG. 12A. In FIG. 12C, the protrusion 107 resides within the holes 109 shown as black circles, while the remaining holes 109 shown as white circles remain empty. With this arrangement, the protrusion 107 may be positioned in a corresponding pair of holes 109 to achieve the desired alignment between the primary lens 50 and the secondary lens 60. For example, with continued reference to FIG. 12C, protrusions 107 may be positioned in a corresponding pair of holes 109 to achieve centered (nominal), right shift, left shift, up shift, down shift, clockwise or counterclockwise (labeled C1-C7, respectively) alignment between primary lens 50 and secondary lens 60. This arrangement provides for various adjustments as described with respect to FIGS. 9A-9D. Additionally, any suitable number of attachment mechanisms 105 may be evenly or unevenly positioned around the circumference of lens 50 and lens 60.

[0037] All or a portion of the various subsurface attachment means described herein may be formed by molding, cutting, milling, etching, or a combination thereof. For example, with particular reference to FIG. 11A, the groove 104 may be formed by in situ laser etching of an existing implanted primary lens 50, and the protrusion may be pre-formed by molding, milling or cutting of the secondary lens 60.

[0038] Examples of lasers that may be used for in situ etching include femtosecond lasers, titanium sapphire lasers, diode lasers, YAG lasers, argon lasers, and other lasers in the visible, infrared, and ultraviolet ranges. Such lasers may be controlled in terms of energy output, spatial control, and temporal control to achieve the desired etching structure and pattern. For example, in situ etching may be achieved by transmitting a laser beam from an external laser source through the cornea and past the pupil. Alternatively, in situ etching may be achieved by transmitting a laser beam from a flexible fiber optic probe inserted into the eye.

[0039] 13A and 13B, photomicrographs at 4X and 40X magnification, respectively, show how a groove (see arrow) was experimentally etched in the primary lens by laser etching. Femtosecond laser settings within the following ranges may be used to etch the groove: power from 1 nJ to 100 μJ, pulse durations in the 20 fs to picosecond range or less, and frequencies from 1 to 250 kHz.

[0040] The primary and secondary components of the modular IOL systems disclosed herein may be formed of the same, similar, or different materials. Suitable materials may include, for example, acrylic-based materials, silicone materials, hydrophobic or hydrophilic polymers, and such materials may have shape-memory properties. For example, materials included in the optic portion of the modular lens system may be silicone, PMMA (polymethyl methacrylate), hydrogel, hydrophobic acrylic, hydrophilic acrylic, or other transparent materials commonly used in intraocular lenses. Non-optical components of the modular IOL may include nitinol, polyethylene sulfone, and / or polyimide.

[0041] Materials may be selected to aid in the performance of certain functions of the modular lens system, particularly the attachment and removal functions required for the primary and secondary lenses as previously described. Other functions of the modular lens that may be enhanced by specific material selections include manufacturability, intra- and post-operative handling, fixation (both intra-operative and during post-operative revision), the small incision size achieved (≦2.4 mm), and interchangeability (minimal trauma upon explantation of the lens).

[0042] For example, in one embodiment, the primary and secondary lenses are made from a hydrophobic acrylic material having a glass transition temperature of about 5-30° C. and a refractive index of about 1.41-1.60. In another embodiment, the primary and secondary lenses may be made from different materials having different glass transition temperatures and mechanical properties to aid in the fixturing and separation characteristics of the modular system. In another embodiment, both or either of the modular lens systems are made from a material that allows compression to an outer diameter equal to or less than about 2.4 mm.

[0043] Generally desirable material properties in modular IOL systems include minimal or no glitter formation, minimal pitting when exposed to YAG laser application, and passing standard MEMs elution tests and other biocompatibility tests according to industry standards. Materials may include various chromophores that enhance the UV blocking capabilities of the substrate. Generally, wavelengths below 400 nm are blocked by standard chromophores at concentrations ≦1%. Alternatively or in addition, materials may include blue light blocking chromophores, such as yellow dyes, that block desired regions of the blue light spectrum. Suitable materials are generally resistant to damage such as surface abrasion, cracking, or haze caused by mechanical trauma under standard implantation techniques.

[0044] The components of the modular IOL may be formed by conventional techniques such as molding, cutting, milling, etching, or combinations thereof. As an alternative to mechanical attachment, chemical attraction between the primary and secondary components may be utilized. The use of similar materials with smooth surface finishes may promote chemical attraction. Chemical attraction may be enhanced by surface activation techniques such as plasma or chemical activation. In some cases, it may be desirable to reduce chemical attraction to avoid sticking between materials and rely more on mechanical attachment for stability. In this case, the primary and secondary components may be formed of different materials or have adjacent surfaces that would otherwise not have chemical attraction.

[0045] With reference to Figures 14-14C, an alternative modular IOL 140 is shown in anterior view, cross-section and detailed view, respectively. Figure 14A shows a cross-section taken along line AA in Figure 14, Figure 14B shows a cross-section taken along line BB in Figure 14, and Figure 14C shows a detailed view of circle C in Figure 14B. The modular IOL 140 may include a primary lens 50 with haptics 54 and a secondary lens 60. As best seen in Figures 14A and 14B, the interface of the primary lens 50 (anterior surface) and the secondary lens 60 (posterior surface) may be in intimate contact. Maintaining intimate contact (i.e., avoiding gaps) or maintaining a certain gap between the interface of the primary lens 50 and the secondary lens 60 may reduce the likelihood of inducing astigmatism. However, in some embodiments, a substance (e.g., adhesive) may be disposed between the surfaces of the lenses 50 and 60. A circular extension may be formed in the secondary lens 60 and a similarly sized and shaped circular recess may be formed in the primary lens 50 to form an interference fit between them, thus securely connecting the two components. The depth of the recess in the primary lens 50 may be a portion of the thickness of the secondary lens 60, and the circular extension of the secondary lens 60 extends over a portion of the primary lens 50, thereby forming an overlap joint 142 as best seen in FIG. 14C. The overlap joint 142 may extend 360 degrees or a portion thereof around the periphery of the secondary lens 60 as shown. The circular extension of the secondary lens 60 rises beyond the anterior surface of the primary lens 50 to form a raised portion. In some embodiments, the raised portion may have a radially tapered configuration. The raised portion may be radially compressed with forceps to facilitate connection and separation of the primary lens 50 and the secondary lens 60. The use of radial compression to insert the secondary lens 60 into the primary lens 50 reduces the anterior-posterior forces applied to the capsular bag during insertion, thereby reducing the risk of capsule rupture.

[0046] With reference to Figures 15-15D, an alternative modular IOL 150 is shown in front view, cross section and detail view, respectively. Figure 15A shows a cross section taken along line AA in Figure 15, Figure 15B shows a cross section taken along line BB in Figure 15, Figure 15C shows a detail view of circle C in Figure 15B, and Figure 15D shows an alternative detail view of circle C in Figure 15B. The modular IOL 150 may include a primary lens 50 with haptics 54 and a secondary lens 60. As best seen in Figures 15A and 15B, the interface of the primary lens 50 (anterior surface) and the secondary lens 60 (posterior surface) may be in intimate contact. The primary lens 50 may include a recess defining a wall within which a similarly sized and shaped circular secondary lens 60 may be disposed. The wall defined by the recess in the primary lens 50 may extend around the entire circumference of the primary lens except for two diametrically opposed gaps 152. The gap 152 thus exposes the peripheral edge of the secondary lens 60 as seen in FIG. 15A to facilitate insertion and removal, for example, by radial compression of the secondary lens 60 using forceps. The remainder of the wall defined by the recess in the primary lens may provide a flush interface, as seen in FIGS. 15B and 15C, where the anterior surface of the secondary lens 60 is flush with the anterior surface of the primary lens 50. As seen in FIG. 15C, the interfacing edges of the wall defined by the recess in the primary lens 50 and the secondary lens 60 may be inwardly angled to provide an interface 154 having a secure mechanical capture and stable interlocking therebetween. Alternatively, as seen in FIG. 15D, the interfacing edges of the wall defined by the recess in the primary lens 50 and the secondary lens 60 may be "S" shaped to provide an interface 156 having a secure mechanical capture and stable interlocking therebetween. Alternate interlocking structures may be used.

[0047] With reference to Figures 16-16D, an alternative modular IOL 160 is shown in front view, cross section and detail view, respectively. Figure 16A shows a cross section taken along line AA in Figure 16, Figure 16B shows a cross section taken along line BB in Figure 16, Figure 16C shows a detailed view of circle C in Figure 16B, and Figure 16D shows a detailed view of circle D in Figure 16A. The modular IOL 160 may be constructed similarly to the modular IOL 150 shown in Figures 15-15D, in which the primary lens 50 includes a recess defining a wall within which a similarly sized and shaped circular secondary lens 60 may be disposed. However, in this embodiment, an angled gap 162 (rather than gap 152) is provided along a portion of the periphery of the secondary lens 60. The wall defined by the circumferential portion of the peripheral edge of the secondary lens 60 may have the same structure as the wall defined by the recess in the primary lens 50 to provide a flush interface 154 as best seen in Figure 16C. The wall defined by another (e.g., remaining) circumferential portion of the peripheral edge of the secondary lens 60 may have a more inwardly angled configuration to provide an angled gap 162 as best seen in Figure 16D. The angled gap 162 thus exposes the peripheral edge of the secondary lens 60 as seen in Figure 16D where a forceps may be placed to facilitate insertion and removal by radial compression of the secondary lens 60. Alternative gap configurations may also be used.

[0048] With reference to Figures 17-17C, an alternative modular IOL 170 is shown in front, cross-sectional, detailed and isometric views, respectively. Figure 17A shows a cross-sectional view taken along line AA in Figure 17, Figure 17B shows a detailed view of circle B in Figure 17A, and Figure 17C shows an isometric view of the assembled components. The modular IOL 170 may be constructed similarly to the modular IOL 150 shown in Figures 15-15D, in which the primary lens 50 includes a recess defining a wall within which a similarly sized and shaped circular secondary lens 60 may be disposed. However, in this embodiment, the wall defining the recess in the primary lens 50 includes portions thereof that are milled down to define two diametrically opposed tabs 172. The inner peripheral walls of the tabs 172 provide a flush interface 174 as seen in Figure 17B such that the anterior surface of the secondary lens 60 is flush with the anterior surface of the primary lens 50. The interface of the joint 174 along the tab 172 may be, for example, angled, "S" shaped, or "C" shaped as shown. Elsewhere along the periphery away from the tab 172, in areas where the wall has been skived, the peripheral edge of the secondary lens 60 is exposed as seen in FIG. 17C to facilitate insertion and removal of the secondary lens 60 by radial compression thereof using, for example, forceps.

[0049] With reference to Figures 18-18C, an alternative modular IOL 180 is shown in front, cross-sectional, detailed and isometric views, respectively. Figure 18A shows a cross-sectional view taken along line AA in Figure 18, Figure 18B shows a detailed view of circle B in Figure 18A, and Figure 18C shows an isometric view of the assembled components. The modular IOL 180 may be constructed similarly to the modular IOL 170 shown in Figures 17-17C, in which the primary lens 50 includes a recess defining a partial wall within which a similarly sized and shaped circular secondary lens 60 may be positioned in engagement with tabs 172 by flush joints 174. However, in this embodiment, each of the tabs 172 and adjacent portions of the secondary lens 60 are provided with a gripping recess or hole 182. In one embodiment, the gripping recess or hole 182 may not extend through the entire thickness of the primary lens 50 and the secondary lens 60. The gripping holes 182 in the secondary lens 60 facilitate insertion and removal by radial compression, for example, using forceps, of the secondary lens 60. The tab portion 172 and adjacent gripping holes 182 in the secondary lens 60 may be pulled together or pushed apart in a radial direction to facilitate connection and disconnection, respectively, of the joint portion 174, for example, using forceps.

[0050] Using a radial force applied through the gripping holes 182 to connect and separate (or lock and unlock) the interface 174 between the primary lens 50 and the secondary lens 60 reduces the anterior-posterior force applied to the capsular bag, thereby reducing the risk of capsule rupture. The gripping holes 182 may also be used to facilitate connection and separation of different mating structures while minimizing anterior-posterior forces. For example, the recess in the primary lens 50 may include female threads that engage corresponding male threads on the peripheral edge of the secondary lens 60. In this embodiment, forceps inserted into the gripping holes 182 may be used to facilitate rotation of the secondary lens 60 relative to the primary lens 50 to screw and unscrew the primary and secondary lenses 50 and 60. In an alternative embodiment, a keyed extension of the secondary lens 60 may be inserted into a keyed opening in the primary lens 50 and rotated using forceps inserted into the gripping holes 182 to lock and unlock the primary and secondary lenses 50 and 60. In another alternative embodiment, forceps or the like may be inserted rearward through the hole in the secondary lens 60 to grasp a front protrusion of the primary lens 50, such as a handle (not shown), and then apply rearward pressure to the secondary lens 60 while holding the primary lens 50 stationary. The grasping hole 182 may also be used to rotate the secondary lens 60 relative to the primary lens 50, for purposes of rotational adjustment in toric applications, for example.

[0051] With reference to Figures 19-19D, an alternative modular IOL 190 is shown in a front view, a cross-section view, a detailed view, an isometric exploded view, and an isometric assembled view, respectively. Figure 19A shows a cross-section view taken along line AA in Figure 19, Figure 19B shows a detailed view of circle B in Figure 19A, Figure 19C shows an exploded isometric view of the components, and Figure 19D shows an assembled isometric view of the components. The modular IOL 190 differs from some of the previously described embodiments in that the primary component serves as the base 55 but does not necessarily provide optical correction, while the secondary component serves as the lens 65 and provides optical correction. The base 55 may be configured in the shape of a ring or annulus having a central opening 57 therein extending in the anterior-posterior direction. In some embodiments, the base 55 may not define a complete ring or annulus. The base 55 may also include haptics 59 similar in function to the haptics 54 described above but with a different geometric configuration. Generally, the haptic 54 / 59 functions to center the base 55 within the capsular bag. Such a haptic may also be configured to apply outward tension to the inner equatorial surface of the capsular bag to aid in symmetric healing and maintain centering of the base, similar to a capsular bag expansion ring. The haptic 59 may include one or more openings therein.

[0052] The base 55 includes a central opening 57 so that the posterior optical surface of the lens 65 is not in contact with the base 55. A circular extension may be formed in the lens 65 and a similarly sized and shaped circular recess may be formed in the base 55 to form an overlapping joint 192 with a protrusion on the base 55 having an interference and / or friction fit therebetween, so that the two components are securely connected. Alternatively, the shape of the overlapping joint 192 may form an oblique angle or an "S" shape as described above, forming an interlock therebetween. The joint or joint 192 may include a modified surface to reduce light scattering due to the joint 192. For example, one or both of the interface surfaces of the joint 192 may be partially to totally opaque or matte (i.e., roughened) to reduce light scattering due to the joint 192.

[0053] 19B, the depth of the recess in the base 55 may be the same thickness as the circular extension of the lens 65 such that the anterior surface of the lens 65 is flush with the anterior surface of the base 55. With this arrangement, the posterior surface of the lens 65 extends further posteriorly than the anterior surface of the base 55. In some embodiments, however, the anterior surface of the lens 65 may be disposed relatively higher or lower than the anterior surface of the base 55. The dimensions of the recess and the corresponding protrusion in the base 55 may be selected relative to the thickness of the lens 65 such that at least a portion of the posterior-most surface of the lens 65 is flush with the posterior-most surface of the base 55 or such that at least a portion of the posterior-most surface of the lens 65 is posterior to the posterior-most surface of the base 55.

[0054] As with the previous embodiment, the lens may be replaced with a different lens either intraoperatively or postoperatively. This may be desirable, for example, if the first lens does not provide the desired refractive correction, in which case the first lens may be replaced with a second lens having a different refractive correction without disturbing the lens capsule. For example, if the lens 65 does not have the desired optical alignment due to base movement or misalignment, it may be replaced with a different lens having an optic portion manufactured to be offset relative to the base 55. For example, the optic portion of the second lens may be offset rotationally, laterally and / or axially, similar to the embodiment described with respect to Figures 9A-9D. This concept may be applied to other embodiments herein where a secondary component (e.g., lens) has limited positional adjustability relative to a primary component (e.g., base).

[0055] The general form of this embodiment has many advantages associated with it, some of which are described below. For example, the posterior optical surface of the lens 65 is not in contact with the base 55, eliminating the possibility of debris being trapped therebetween. Also, by way of example, because the base 55 includes a central opening 57 that is free of material, the base 55 can be rolled to a smaller diameter than the primary lens 50 described above to facilitate delivery through a smaller incision in the cornea. Alternatively, the base 55 may have a larger outer diameter and be rolled to a similar diameter as the primary lens 50. For example, the base lens 55 may have an outer diameter (excluding haptics) of about 8 mm and be rolled to the same diameter as the primary lens 50, which has an outer diameter of 6 mm. This may allow at least a portion of the bond between the base 55 and the lens 65 to move radially outward away from the circumferential edge of the capsulorhexis, which typically has a diameter of 5-6 mm. Moving at least a portion of the bond between the base 55 and the lens 65 radially outward from the periphery of the capsulorhexis can reduce the amount of bond in the field of view, and therefore may reduce the likelihood of light scattering or optical aberrations (e.g., dysphotopsia). Of course, notwithstanding this example, any suitable dimension may be selected to provide a gap between the lens 65 and the peripheral edge of the capsulorhexis to alleviate the need to manipulate the lens capsule to couple or separate the lens 65 from the base 55.

[0056] With reference to Figures 20-20D, an alternative modular IOL 200 is shown in a front view, a cross-section view, a detailed view, an isometric exploded view, and an isometric assembled view, respectively. Figure 20A shows a cross-section view taken along line AA in Figure 20, Figure 20B shows a detailed view of circle B in Figure 20A, Figure 20C shows an exploded isometric view of the components, and Figure 20D shows an assembled isometric view of the components. The modular IOL 200 includes a base 55 with corresponding haptics 59 and a lens 65. The base 55 includes a central hole 57 such that the posterior optical surface of the lens 65 does not contact the base 55. The lens 65 includes a circular extension sized and shaped to fit into a circular recess formed in the base 55 to form a protrusion on the base 55 and an overlapping interface 202. The overlapping interface 202 may be configured by an "S" shaped interface to securely connect the two components. Thus, modular IOL 200 is similar to modular IOL 190, except that interface 202 between base 55 and lens 65 may include a peg and hole arrangement. In this arrangement, a pair of diametrically opposed pegs 204 may extend posteriorly from the posterior periphery of lens 65 and may fit within a selected pair of holes 206 from a series of holes 206 formed in a protrusion of interface 202 of base 55.

[0057] 20E-20I show further details of the modular IOL 200. FIG. 20E shows a side view of the lens 65, FIG. 20F shows a rear view of the posterior surface of the lens 65, FIG. 20G is a detail of circle G of FIG. 20E, FIG. 20H is a front view of the anterior surface of the base 55, and FIG. 20I is a detail of circle I of FIG. 20H. As seen in FIG. 20E-20F, a pair of diametrically opposed pegs 204 may extend posteriorly from the posterior periphery of the lens 65. As seen in FIG. 20H-20I, the inner diameter of the base 55 along with the projection of the joint 202 may include a series of holes 206 into which a pair of pegs 204 may be inserted. This arrangement may allow the lens 65 to be selectively rotated relative to the base 55, for example, for purposes of rotational adjustment in toric applications.

[0058] With reference to Figures 21-21E, an alternative modular IOL 210 is shown in front view, cross section, detail view, and isometric view, respectively. Figures 21A and 21B show cross sections taken along lines AA and BB, respectively, of Figure 21. Figures 21C and 21D show detail views of circle C of Figure 21A and circle D of Figure 21B, respectively. Figure 21E shows an isometric view of the assembled components of the modular IOL 210. The modular IOL 210 may be configured similarly to the combination of the modular IOL 190 shown in Figures 19-19D and the modular IOL 170 shown in Figures 17-17C. Similar to the modular IOL 190, the modular IOL 210 includes a base 55 configured in the shape of a torus or ring with a central opening and a recess defining a wall. A circular lens 65 of similar size and shape may be placed within the recess. Similar to modular IOL 170, the wall defines a recess extending along the inner circumference of base 55, a portion of which is skived to define two diametrically opposed tabs 212. The inner peripheral wall of tab 212 provides a flush interface 214 as seen in FIG. 21C such that the anterior surface of lens 65 is flush with the anterior surface of base 55. The interface of interface 214 along tab 212 may be sloped, for example, in an "S" shape or as shown, in a "C" shape. Elsewhere along the circumference away from tab 212, in the area where the wall is skived, the peripheral edge of lens 65 is exposed as seen in FIG. 21D to facilitate insertion and removal of lens 65 by radial compression using forceps, for example.

[0059] With reference to Figures 22-22D, an alternative modular IOL 220 is shown in front view, cross section and detailed view, respectively. Figure 22A shows a cross section taken along line AA in Figure 22, Figure 22B shows a cross section taken along line BB in Figure 22, Figure 22C shows a detailed view of circle C in Figure 22A, and Figure 22D shows a detailed view of circle D in Figure 22B. The modular IOL 220 includes a base 55 with corresponding haptics 59 and a lens 65. The base 55 includes a central hole such that the posterior optical surface of the lens 65 does not contact the base 55. The periphery of the lens 65 is sized and shaped to fit into a circular recess formed in the base 55 to form a flush interface 222 with a protrusion on the base 55. The flush interface 222 may be configured by an "S" shaped interface to securely connect the two components. A pair of pegs 224 extend forwardly from the base 55 near its inner periphery and through a pair of arc-shaped slots 226 near the periphery of the lens 65. As shown in Figure 22, the arc-shaped slots may extend along a portion of the periphery of the lens 65. This arrangement allows the lens 65 to be selectively rotated relative to the base 55, for example, for purposes of rotational adjustment in toric applications.

[0060] Peg 224 may be sized and configured to overhang the anterior surface of lens 65, as shown in FIGURE 22C. Forceps or the like may be inserted rearwardly through arc-shaped slot 226 in lens 65 to grasp peg 224 like a handle and then apply rearward pressure to lens 65 while holding peg 224 stationary. By holding peg 224 during coupling of lens 65 to base 55, and thus stabilizing base 55, the anterior-posterior forces applied to the lens capsule are reduced, thereby reducing the risk of capsule rupture.

[0061] 23A-23D, a lens removal system for a modular IOL according to one embodiment of the present disclosure is shown diagrammatically. FIGS. 23A and 23B are side and top views, respectively, of the lens removal system. FIGS. 23C and 23D are top views illustrating how the lens removal system may be used to remove the lens 60 / 65. The lens removal or extractor system may include a cannula 230 and a pair of forceps 235. The cannula 230 may include an inner lumen sized to slidably receive the forceps 235. The cannula 230 may include a tubular shaft 232 and a beveled distal opening 234. The cannula 230 may be shaped and configured similarly to a conventional IOL insertion device, for example. The forceps 235 include a pair of atraumatic grasping tips 237 and a tubular shaft 239. The tips 237 may be compressed and the tubular shaft 239 may be advanced to grasp the lens 60 / 65. The forceps 235 may be formed and configured similarly to, for example, conventional ophthalmic forceps, except that the tip 237 may be formed of or coated with a relatively soft polymeric material to avoid damaging the lens 60 / 65. In general, any device used to manipulate the modular IOL components described herein may be formed of or coated with a relatively soft polymeric material to avoid damaging the components.

[0062] 23C and 23D, the cannula 230 may be inserted through the corneal incision until its tip is adjacent the capsulotomy. The forceps 235 may be inserted into and through the cannula 230 until the distal tip 237 extends distally beyond the distal end of the cannula 230. The lens 60 / 65 to be extracted may be grasped with the forceps 235 as shown in FIG. 23C. With the lens 60 / 65 held securely by the forceps 235, the forceps 235 may be retracted proximally into the cannula 230. As the forceps 235 is retracted into the cannula 230, the lens 60 / 65 enters a contoured opening 234. The contoured opening 234 encourages the edges of the lens 60 / 65 to roll and fold as seen in FIG. 23D. The forceps 235 are then fully retracted into the cannula 230, safely trapping the lens 60 / 65 in the lumen of the cannula 230 after which it may be removed from the eye. A similar technique may also be used to reverse the relevant steps and insert the lens 60 / 65.

[0063] 24-26 describe exemplary methods of using a modular IOL according to embodiments of the present disclosure. By way of example, and not necessarily limited to, described with respect to a primary lens and a secondary lens, the same or similar methods may be applied to other modular IOL embodiments, including those modular IOL embodiments described herein that include a base and a crystalline lens.

[0064] With reference to FIG. 24, a method for using a modular IOL according to one embodiment of the present disclosure is illustrated in a schematic flow chart. In this example, the secondary lens may be replaced if a suboptimal optical outcome is detected intraoperatively. An IOL implantation procedure, such as cataract surgery, may be initiated 110 according to conventional techniques. The natural lens may then be prepared 112 to receive the modular IOL using conventional steps such as creating a corneal access incision, cutting a capsulorhexis in the anterior lens capsule, and removing the cataractous lens by phacoemulsification. A base lens (i.e., primary lens 50) is then placed 114 within the lens capsule. A secondary lens (i.e., secondary lens 60) is then placed 116 on the base lens within the periphery of the capsulorhexis without touching or otherwise disturbing the lens capsule. An attachment means is then engaged 118 to releasably couple the secondary lens to the base lens. Alternatively, the secondary lens may be attached to the base lens prior to placement in the lens capsule, such that the base lens and secondary lens are inserted together as a unit. With both the base lens and secondary lens in place, the optical result may be measured 120, for example, by intraoperative aberrometry. The optical result may take into account refractive correction, centrality, toricity correction, etc. A determination 122 is then made as to whether the optical result is optimal or sub-optimal. If the optical result is optimal or otherwise adequate, the IOL procedure is completed 124. However, if the optical result is sub-optimal or otherwise inadequate, the attachment means may be separated 126 and the secondary lens may be removed 128. A different secondary lens may then be placed 116 on the base lens following the same subsequent steps as shown. The different secondary lenses may have, for example, different refractive powers to correct refractive error, different offsets to correct decentration, or different toricity errors. The lenses may have different toric powers for correction of the ocular refractive error.

[0065] With reference to FIG. 25, an alternative method for using a modular IOL according to one embodiment of the present disclosure is illustrated in a schematic flow chart. In this example, the secondary lens may be replaced if a suboptimal optical result is detected postoperatively. The same steps 110-118 and 124 may be performed as described above, except that the patient is allowed to acclimate 130 to the modular IOL for, for example, one to four weeks or more. At a return visit, the optical result is measured 120 and a determination 122 is made as to whether the optical result is optimal or suboptimal. If the optical result is optimal or otherwise adequate, the procedure is stopped 132. If the optical result is suboptimal or otherwise inadequate, a corrective procedure may be initiated 134 to replace the secondary lens according to steps 126, 128, 116, and 118 described above.

[0066] This method may be advantageous in that it allows the lens capsule to heal before determining if the optical result is satisfactory, and the healing process alters the position of the primary and / or secondary lens. This method may also be applied on a chronic basis where the patient's vision needs or demands change over a longer period of time (e.g., >1 year). In this example, the patient may require or desire different corrections, such as stronger refractive, toric or multifocal corrections, each of which may be addressed with a different secondary lens.

[0067] With reference to FIG. 26, another alternative method for using a modular IOL according to an embodiment of the present disclosure is illustrated in a schematic flow chart. In this example, a secondary lens may be implanted in a patient 138 with an existing IOL that is optically suboptimal or does not meet the patient's needs and desires. After the procedure begins 110, an attachment mechanism may be formed (step 140) in situ in the existing (base) IOL using, for example, laser etching to form a groove as described above. The formation of the groove may be performed within the perimeter of a pre-cut capsulotomy to avoid touching or disturbing the lens capsule. The secondary lens may then be placed 116 on the base lens within the perimeter of the capsulotomy, and an attachment mechanism may be engaged 118 to couple the secondary lens to the base lens, and the procedure may be completed 124 as described above.

[0068] With reference to Figures 27-27D, an alternative modular IOL 270 is shown in front view, cross section and detailed view, respectively. Figures 27A and 27B show cross sections taken along lines AA and BB, respectively, of Figure 27. Figures 27C and 27D show detailed views of circle C of Figure 27A and circle D of Figure 27B, respectively. The modular IOL 270 may be configured similarly to the modular IOL 210 shown in Figures 21-21D. Like the modular IOL 210, the modular IOL 270 includes a base 55 configured in the shape of a torus or ring, with a central opening and a recess defining a wall within which a similarly sized and shaped circular lens 65 may be placed. Also like the modular IOL 210, the wall defining the recess extends along the inner circumference of the base 55, a portion of which is milled to define two diametrically opposed tabs 272. The interior peripheral wall of tab 272 provides a flush joint 274 as seen in FIG. 27C so that the anterior surface of lens 65 is flush with the anterior surface of base 55. The interface of joint 274 along tab 272 may be tapered, for example, in an "S" shape or a "C" shape as shown. Elsewhere along the periphery away from tab 272, in areas where the wall has been skived, the peripheral edge of lens 65 is exposed as seen in FIG. 27D to facilitate insertion and removal of lens 65 by radial compression using, for example, forceps.

[0069] Because the base 55 includes a central opening that is free of material, the base 55 can be rolled into a delivery configuration that has a larger outer optical diameter (excluding haptics), for example, about 8 mm, yet is small enough to fit into a corneal incision, for example, less than about 2.4 mm. This can allow at least a portion of the bond between the base 55 and the lens 65 to be moved radially outward away from the circumferential edge of the capsulorhexis, which typically has a diameter of 5-6 mm. Moving at least a portion of the bond between the base 55 and the lens 65 radially outward from the periphery of the capsulorhexis can reduce the amount of bond in the field of view, and therefore the potential for light scattering or optical aberrations (e.g., dysphotopsia).

[0070] To further illustrate this advantage, consider a standard (single component) IOL, which typically has a conventional crystalline lens optical diameter of 6 mm. An IOL with a 6 mm diameter optic can be rolled and delivered through a 2.2 mm corneal incision. To ensure secure fixation of the standard IOL within the capsular bag, the capsular incision is typically sized to allow the capsular bag to completely capture the standard IOL after the bag has collapsed and healed. This would lead the surgeon to create a capsular incision with a diameter of approximately 4.5 mm to 5.5 mm.

[0071] Now consider IOL 270 by comparison. The modular (two-piece) nature of IOL 270 and the hole in base 55 allows both components (base 55 and lens 65) to be rolled and delivered through a small corneal incision (e.g., 2.2 mm), but does not require a 4.5 mm to 5.5 mm capsulotomy. Conversely, because the base has a diameter of 8 mm (excluding haptics), the capsulotomy diameter may be larger (e.g., 6.0 mm to 6.5 mm), which allows the lens 65 to fit comfortably inside the periphery of the capsulotomy while allowing the coupling 274 to be more peripheral to further minimize light scattering. Of course, regardless of these examples, any suitable dimensions may be selected to provide a gap between the lens 65 and the peripheral edge of the capsulotomy to alleviate the need to manipulate the lens capsule to couple or separate the lens 65 from the base 55. (Additional Note) As a preferred embodiment, the technical ideas that can be understood from the above embodiment will be described below. [Section 1] 1. An intraocular lens system for implantation within a lens capsule having a capsular incision having a periphery, the intraocular lens system comprising: a. a primary intraocular component having a body and one or more haptics, said primary component configured to fit within said lens capsule, said body having an equatorial circumference greater than or equal to the circumference of said capsulotomy; b. an intraocular sub-component having an optic body with an equatorial perimeter that is less than the perimeter of the capsulotomy; c. the primary component is configured to removably receive and couple to the secondary component to provide optical correction; system. [Section 2] Item 1. The system of item 1, wherein the primary component includes a central bore extending in a front-to-rear direction, the bore being sized and configured to receive the secondary component. [Section 3] Item 3. The system of item 2, wherein the posterior-most optical surface of the secondary component extends posterior to the anterior surface of the primary component. [Section 4] Item 4. The system of item 3, wherein at least a portion of the rearmost optical surface of the secondary component is flush with the rearmost surface of the primary component. [Section 5] Item 5. The system of item 4, wherein at least a portion of the rearmost optical surface of the secondary component is posterior to the rearmost surface of the primary component. [Section 6] Item 1. The system of item 1, wherein the primary component and the secondary component are connected at a joint, and at least a portion of the joint includes a modified surface for reducing light scattering caused by the joint. [Section 7] Item 7. The system of item 6, wherein the modified surface is at least partially opaque to reduce light scattering due to the bond. [Section 8] Item 7. The system of item 6, wherein the modified surface is at least partially matte to reduce light scattering due to the bond. [Section 9] Item 2. The system of item 1, wherein the primary component is a base and the secondary component is a lens. [Section 10] Item 1. The system of item 1, wherein the primary component is a primary lens and the secondary component is a secondary lens. [Section 11] Item 11. The system of item 10, wherein a posterior optical surface of the secondary lens is in intimate contact with an anterior optical surface of the primary component. [Section 12] Item 11. The system of item 10, wherein the primary lens and the secondary lens, in combination, provide a desired optical correction. [Section 13] Item 1 . The system of item 1 , wherein the sub-component excludes a support. [Section 14] Item 2. The system of item 1, wherein the equatorial diameters of the sub-components are configured to lie within the perimeter of the capsulotomy and define a radial gap therebetween. [Section 15] Item 1. The system of item 1, wherein the secondary component is secured to the primary component by a mechanical attachment, at least a portion of the mechanical attachment is configured to be within the perimeter of the capsular incision, and the mechanical attachment can be engaged and disengaged by application of one of an axial force or a rotational force. [Section 16] Item 16. The system of item 15, wherein the mechanical attachment portion includes one of a mating structure or a meshing structure coupled to the primary component and the secondary component. [Section 17] Item 16. The system of item 15, wherein the mechanical attachment portion includes two pairs of mating structures diametrically opposed and adjacent peripheral edges of the sub-component. [Section 18] Item 18. The system of item 17, wherein the mating structure is aligned with a winding axis about which the component is wound for delivery into the lens capsule. [Section 19] Item 16. The system of item 15, wherein the mechanical mounting portion includes a protrusion and a recess. [Section 20] 20. The system of claim 19, wherein the recess is formed in one of the main component and the sub-component, and the protrusion is formed in the other of the main component and the sub-component. [Section 21] Item 20. The system according to item 19, wherein the recess is formed in situ in vivo. [Section 22] Item 13. The system of item 1, wherein the secondary component is immobilized to the primary component by chemical attraction. [Section 23] 23. The system of claim 22, wherein the contact surface of the primary component and the contact surface of the secondary component are formed of the same material. [Section 24] 24. The system of claim 23, wherein the contact surfaces of the primary component and the contact surfaces of the secondary component are chemically treated to activate the surfaces. [Section 25] Item 11. The system of item 1, wherein the connection of the primary component to the secondary component is adjustable in one of the following directions: rotationally, laterally (side to side), or axially (front to back). [Section 26] 1. A method for implanting an intraocular lens (IOL), comprising: a. preparing the natural lens capsule for implantation of an IOL, including forming a capsulotomy; b. placing a primary component within the lens capsule; c. securing a secondary component to the primary component within the periphery of the capsulotomy; A method comprising: [Section 27] 27. The method of claim 26, wherein the primary component and the secondary component are connected at a junction having a perimeter, at least a portion of the junction perimeter being larger than the perimeter of the capsulotomy to reduce the possibility of light scattering and dysphotopsia associated with the junction. [Section 28] 27. The method of claim 26, further comprising removing the secondary component from the primary component without disrupting the lens capsule associated with the primary component. [Section 29] 30. The method of claim 28, further comprising the step of fixing a different sub-component having different optical properties than the primary component without destroying the lens capsule associated with the primary component. [Section 30] 1. A method for implanting an intraocular lens (IOL), comprising: a. forming at least a portion of a mechanical attachment on an IOL that has been pre-implanted within a periphery of a capsulorhexis; b. fixing a sub-component to the pre-implanted IOL within the periphery of the capsulorhexis; A method comprising:

Claims

1. 1. A modular intraocular lens system for implantation within an eye, comprising: (a) an annular base having an inner periphery defining a central bore and an outer periphery with two or more supports extending outwardly therefrom, the inner periphery including a continuous circumferential recess having a protrusion extending entirely about the inner periphery, the continuous circumferential recess having a forward rim and an aft rim; (b) a lens disposed within the continuous circumferential recess on the protrusion of the annular base over the central hole, an overlapping joint being formed between the lens and the annular base, the joint being configured to permit insertion and removal of the lens into and from the annular base; Equipped with (c) the lens has an optical axis and a rest position along the optical axis relative to the annular base when disposed within the continuous circumferential recess; (d) a modular intraocular lens system, wherein the lens comprises a pair of slots configured to allow for change in a rotational position of the lens relative to the annular base, and a pair of pegs extending from the annular base are disposed within the pair of slots.

2. The modular intraocular lens system of claim 1 , wherein the pair of pegs extend anteriorly from the annular base.

3. The modular intraocular lens system of claim 2 , wherein the pair of pegs are adjacent the inner periphery of the annular base.

4. The modular intraocular lens system of claim 1 , wherein the pair of pegs are diametrically opposed.

5. The modular intraocular lens system of claim 1 , wherein the pair of pegs comprises a first peg and a second peg, the first peg being spaced apart from the second peg.

6. The modular intraocular lens system of claim 1 , wherein the pair of slots are near a periphery of the lens.

7. The modular intraocular lens system of claim 6 , wherein the pair of slots are diametrically opposed.

8. The modular intraocular lens system of claim 1 , wherein the pair of slots have an arc shape.

9. The modular intraocular lens system of claim 1 , wherein each of the pair of slots extends along a portion of the periphery of the lens.

10. 1. A modular intraocular lens system for implantation within an eye, comprising: (a) an annular base having an inner periphery defining a central bore and an outer periphery with two or more supports extending outwardly therefrom, the inner periphery including a continuous circumferential recess having a protrusion extending entirely about the inner periphery, the continuous circumferential recess having a forward rim and a rearward rim, the forward rim having an inner diameter greater than the inner diameter of the rearward rim; (b) a lens having an optic portion and a periphery, the optic portion having an optical axis, the optic portion being disposed over the central hole and the periphery being disposed within the continuous circumferential recess on the protrusion of the annular base to form an overlapping interface, the interface being configured to permit insertion and removal of the lens into and from the annular base, the lens further having a pair of slots adjacent the periphery; Equipped with (c) the lens has a rest position along the optical axis relative to the annular base when disposed within the continuous circumferential recess; (d) a modular intraocular lens system, wherein the pair of slots are configured to allow for variation in rotational position of the lens relative to the annular base.

11. The modular intraocular lens system of claim 10 , wherein the annular base includes a pair of pegs adjacent the inner periphery, the pair of pegs extending anteriorly from the annular base.

12. The modular intraocular lens system of claim 11 , wherein the pair of pegs extend through the pair of slots in the lens.

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