Intraocular lenses

Abstract

Intraocular lenses and methods of manufacturing lenses. The lenses may include haptics optionally with a plurality of footplates. The lenses may include one or more anterior surface elements that may be one or more of iris damage resist elements or iris interface rotational resist elements. The lenses may include one or more haptic regions that are adapted to swell more than other adjacent haptic regions. The lenses may include at least three discrete zones. Methods of manufacturing may include delivering ionizing energy to a body to break at least some of the cross-link bonds.

Description

INTRAOCULAR LENSESCLAIM OF PRIORITY

[0001] This application claims priority to the following provisional applications, the entire disclosures of which are incorporated by reference herein in their entireties for all purposes: U.S. Provisional Application No. 63 / 648,645, filed May 16, 2024; U.S. Provisional Application No. 63 / 662,984, filed June 21, 2024; U.S. Provisional Application No. 63 / 715,285, filed November 1, 2024, and U.S. Provisional Application No. 63 / 744,095, filed January 10, 2025.BACKGROUND

[0002] Variability in eye dimensions exists for subjects receiving intraocular lenses, such as posterior chamber lenses. In some cases, it may be necessary to have access to a variety of lens sizes such that the best fit lens is implanted for a particular patient. There are benefits to reducing the number of different sizes of lenses that need to be manufactured. Additionally, minimizing tissue damage has clear benefits. Additionally, still, ensuring stability of a lens in the eye has clear benefits. The disclosure and examples herein address at least one or more of these issues.SUMMARY OF THE DISCLOSURE

[0003] The disclosure is related to lenses, optionally vision correction lenses such as intraocular lenses, although concepts herein may find broader applicability, such as with polymeric materials in general.

[0004] One aspect of the disclosure is related to ways of achieving one or more desired mechanical properties for a portion of a lens, such as a non-optic peripheral portion. Nonoptic peripheral portions herein may be referred to as haptic(s) and may optionally include one or more footplate regions of one or more haptics. As used herein, the term haptic can refer to one or more haptic structures of a lens.

[0005] In some examples but not limiting in any way, the lenses may be posterior chamber lenses, such as, without limitation, an Intraocular Collamer Lens (“ICL”); all materials described in W02020 / 037314, US 2020 / 0071440, and W02023 / 060017 are incorporated by reference herein may optionally be used in one or more portions of the lenses). In some examples, the lenses may be intraocular lenses adapted for placement within a capsular bag after a native lens has been removed.

[0006] Lenses herein may have one or more haptic regions, optionally one or more footplate regions, which are adapted with one or more mechanical properties that provide one or more benefits. For example only, a posterior chamber lens (such as an ICL) may be adapted for placement in the posterior chamber, in front of the capsular bag (whether the native lens has been replaced or not), with footplates engaging the ciliary sulcus (referred to herein as the sulcus) and / or the zonules, with at least a portion of the optic within the pupil. The footplates can have mechanical properties (e.g., stiffness) that facilitate deformation (e.g., bending) of the footplates to compensate for varying sulcus dimensions. For example, for smaller patients, the footplates are adapted to bend more and accommodate the smaller internal sizes. For larger posterior chamber sizes, the footplates may not deform significantly but are still able to sufficiently stabilize the lens in the eye. In some examples, and as described in more detail herein, at least a portion of footplates can be irradiated with ionizing energy (e.g., X-rays) to break cross-link bonds in an already cured material and then hydrated to decrease the stiffness of the material (soften the material). This is an example of making the footplates or a region of the footplates relatively quite soft (relative to one or more other parts of the lens, e.g., adjacent haptic regions and / or the optic).

[0007] While the relatively less stiff haptic concept described herein may be helpful with varying posterior chamber sizes, the relative soft footplates may be implemented and useful in scenarios where variation in size is not an objective or is not a primary objective. For example, it may be beneficial for the lens to have relatively soft footplates to prevent or minimize damage to tissue the footplates contact, even if sizing is not a primary concern.

[0008] Some lenses herein may have one or more haptic regions, optionally one or more footplate regions, which can minimize or reduce damage to tissue to which the haptic regions are exposed when implanted, which is generally referred to herein as mitigating tissue damage, such as, without limitation, zonules, ciliary sulcus and / or iris tissue. For example, footplates may be made relatively soft using the ionizing energy approaches herein, wherein the softness mitigates tissue damage. Additionally, for example, footplates may have desired mechanical properties (e.g., increased softness) while having outer surfaces that are smooth or substantially smooth, wherein the smoothness mitigates tissue damage compared to outer surfaces that have, for example, ridges, grooves, or other non-smooth surface features. It is understood that footplates herein that are adapted to mitigate tissue damage may optionally include non-smooth surfaces, such as one or more grooves / ridges (e.g., if there is a lower risk of tissue damage in a certain region). Adaptation for mitigating tissue damage (e.g., softness) may also help with sizing by facilitating deformation, as is discussed herein.

[0009] Any of the imparted mechanical properties of the footplates (or other haptic regions) may also help prevent the lens from contacting the native lens / capsule, thereby reducing the risk of complications such as increasing IOP and glaucoma.

[0010] Any of the footplates may be slightly angled in an anterior direction, which, along with imparted mechanical properties, may also cause the footplate to preferably deform towards and into an anatomical cavity that exists between the haptic and the iris, which can allow the footplates to deform into and occupy the cavity space, facilitating one or more of sizing improvements and optionally minimizing contact with zonules.

[0011] Lenses herein may include optical characteristics (e.g., transparent footplate regions of the haptic) that help measure very small dimensions (e.g., thickness) of the footplates, while also optionally providing the sizing and tissue damage mitigating benefits described herein.

[0012] Lenses herein may optionally include at least three optically discrete regions, with two transparent regions (e.g., footplates and an optic) and a light absorbing haptic region in between, with any of the footplate properties described herein (sizing, mitigating tissue damage, etc.)

[0013] Lenses herein may optionally include at least two optically discrete regions, with a transparent optic and a light absorbing haptic region outside of the optic, with any of the footplate properties described herein (sizing, mitigating tissue damage, etc.).

[0014] Lenses herein may optionally be completely transparent, with haptic features that provide one or more of any of the features herein (sizing, mitigating tissue damage, etc.).

[0015] While footplates herein may help resist lens rotation once implanted, the lenses may additionally or alternatively have one or more one or more iris interface rotational resist elements (for example without limitation, any of the legs / rails herein), which may have mechanical properties that help resist lens rotation in the eye. “Iris interface rotational resist elements” herein (or similar phrases and / or derivatives thereof) refer to one or portions of the haptic that are positioned and sized to interface with the iris and help resist rotation of the lens once implanted. Posterior chamber lenses may include one or more iris interface rotational resist elements disposed and positioned on the anterior surface of the lens and configured so as to interface with (contact) the iris and resist lens rotation. Any of the iris rotational resist elements herein may also be referred to as rotational stabilizers or other similar term that help provide rotational stability to the lens.

[0016] Optional iris interface rotational resist elements herein can have an anterior extent that is greater than adjacent haptic regions (extend further anteriorly than adjacent haptic regions) to minimize the gap between the iris and lens, engage the iris on opposite sides of anaxis or plane, and resist lens rotation. Any of the optional iris interface rotational resist elements herein may also have increased softness (less stiffness) relative to adjacent haptic surfaces to help mitigate damage to the iris pigment epithelium / muscle tissue from the lens.

[0017] Lenses herein may include one or more iris damage mitigating features that comprise one or more regions that are raised (anteriorly) relative to adjacent haptic surfaces and may be preferably softer (less stiff) relative to adjacent haptic surfaces to help maintain a smooth interaction between the lens and iris pigment epithelium / muscle tissue and to prevent or minimize tissue damage.

[0018] Any of the one or more iris damage mitigating elements and / or one or more iris interface rotational resist elements may be regions of the lens that are swollen upon hydration (e.g., in BSS) to a greater extent than adjacent haptic regions, optionally formed by ionizing regions of the lens with x-ray energy to break cross-linked bonds (discussed in more detail herein) and swollen to a greater extent and dimension when hydrated to mitigate tissue damage and / or help resist lens rotation.

[0019] Any of the footplates herein may help provide rotational stability via interaction with zonules / sulcus, while any of the iris interface rotational resist may help provide stability via interaction with the iris. Thus, with lenses herein that include both footplates and iris rotational resist elements (iris rotational resist elements may also be adapted as iris damage mitigating elements), the lens overall can be adapted to resist lens rotation to a greater extent than a lens with only one of footplates or iris rotational resist elements.

[0020] Resisting lens rotation as described herein can be particularly important when correcting astigmatism with toric lenses for which rotational positioning in the eye is critical for proper vision correction.

[0021] Any of the haptic regions exposed to ionizing energy (e.g., x-ray energy) to break at least some of the cross-link bonds in the already-cured material may include a haptic region that has a non-uniform cross-link density (e.g. gradient density) within the region after exposure to the ionizing energy, and which when hydrated creates at least one non-uniform mechanical property to the region (e.g., a gradient stiffness, a gradient refractive index). Alternatively, any of the haptic regions exposed to ionizing energy (e.g., x-ray energy) to break at least some of the cross-link bonds in the already-cured material may include a haptic region that has a uniform cross-link density within the region after exposure to the ionizing energy, and which when hydrated creates a uniform mechanical property to the region. Any of the haptic regions may have a non-variable chemical composition, and a non-uniform or uniform mechanical property when hydrated.

[0022] Any of the lenses herein may have central region outer dimensions that cover pupil sizes up to 8 mm in scotopic conditions. For example only, any of the lenses herein may have central region dimensions (measured through the optical axis) up to 8.5 mm.

[0023] Any of the footplates herein may include an outer edge surface with a non- cylindrical configuration or profile, an example of which is shown in FIG. 1 A. The non- cylindrical configuration may include a flat edge surface or substantially flat edge surface, an example of which is shown as surface 107 in FIG. 1A. By comparison, footplates 506 in FIG. 5 A include an outer edge surface with a more circular or cylindrical configuration or profile.

[0024] An optional example is a lens, optionally sized and configured to interface with a sulcus of an eye, the lens comprising an optic body and a haptic with a plurality of footplates. Each of the plurality of footplates extend further outward relative to adjacent haptic region, and optionally each of the plurality of footplates have less cross-link density than a haptic region closer to the optic body. By having fewer cross-links, the footplates can be made to be more flexible or softer than adjacent haptic region upon swelling.

[0025] An optional example is a method for modifying at least one mechanical property of a haptic region of a lens. The method may comprise, in a cured (polymerized) haptic region of a body, irradiating a plurality of discrete regions of the haptic region with ionizing energy to break at least some of the cross-link bonds in the discrete regions, each of the plurality of discrete regions comprising an anterior surface of the haptic region and spaced apart from each of the other plurality of discrete regions. The method may further comprise hydrating the lens body (which may occur after placement in the eye and / or when placed in a packaging solution prior to implantation), causing the plurality of discrete regions to become raised in the anterior direction relative to adjacent haptic regions.

[0026] An optional example is a lens comprising an optic and a haptic sized and configured to interface with a sulcus of an eye. The haptic optionally has an anterior surface that includes a plurality of iris interface rotational resist elements. The plurality of iris interface rotational resist elements may be raised regions that extend further anteriorly than adjacent haptic regions or recessed regions (or a combination thereof), and which are spaced apart from each other.

[0027] An optional example is a lens comprising an optic and a haptic sized and configured to interface with a sulcus of an eye. The haptic optionally comprises an anterior surface that includes a plurality of iris damage resist elements, each of the plurality of iris damage resist elements are raised regions that extend further anteriorly than adjacent haptic regions, and which are spaced apart from each other. The iris damage resist elements areoptionally more deformable than adjacent haptic regions to reduce the likelihood of iris damage.

[0028] An optional example is a lens comprising an optic and a haptic, the haptic sized and configured to interface with a sulcus of an eye. The haptic optionally comprises a plurality of anterior surface elements that, when the lens is placed in an eye and / or packaging solution, are chemically adapted to swell more and extend further anteriorly than adjacent haptic regions.

[0029] An optional example is a lens, comprising an optic body and a haptic sized and configured to interface with a sulcus of an eye. The haptic optionally includes a plurality of footplates that, prior to being implanted in an eye, are chemically adapted to swell more than adjacent haptic regions when placed in the eye and / or packaging solution.

[0030] An optional example is a lens comprising an optic and a haptic, the haptic sized and configured to interface with a sulcus of an eye. The haptic optionally includes a plurality of anterior surface elements that extend further anteriorly than adjacent haptic regions.

[0031] An optional example is a method that chemically modifies one or more regions of an already cured haptic to cause those regions to swell more than adjacent, non-modified haptic regions.

[0032] One or more features from any of the examples herein (shown and / or described) may be integrated and combined with features of any other example herein unless indicated to the contrary herein.BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Abetter understanding of the features and advantages of the methods and apparatuses described herein will be obtained by reference to the following detailed description that sets forth illustrative embodiments, and the accompanying drawings of which:

[0034] FIGS. 1A, IB and 1C illustrate an exemplary lens with exemplary footplates and anterior surface elements.

[0035] FIG. 2 illustrates an exemplary energy delivery apparatus emitting or delivering energy towards an exemplary body.

[0036] FIG. 3 illustrates exemplary footplates of a lens, illustrating a variation in mechanical properties within the footplates.

[0037] FIG. 4 illustrates an anatomical region between a posterior chamber lens (e.g., an ICL) and an iris.

[0038] FIG. 5 A illustrates an exemplary lens including discrete anterior surface elements spaced apart.

[0039] FIG. 5B illustrates an exemplary lens including discrete anterior surface elements spaced apart.

[0040] FIG. 5C illustrates an exemplary lens including discrete anterior surface elements spaced apart.

[0041] FIG. 5D illustrates an exemplary lens including discrete anterior surface elements spaced apart.

[0042] FIGS. 5E and 5Ee illustrate an exemplary lens including discrete anterior surface elements spaced apart.

[0043] FIGS. 5F and 5G illustrate an exemplary lens including discrete anterior surface elements spaced apart.

[0044] FIGS. 5H, 51, 5J and 5K illustrate an exemplary lens including discrete anterior surface elements spaced apart.

[0045] FIGS. 5L, 5M, 5N and 50 illustrate an exemplary lens including discrete anterior surface elements spaced apart.

[0046] FIGS. 5P, 5Q, and 5R illustrate an exemplary lens including discrete anterior surface elements spaced apart.

[0047] FIGS. 6 A, 6B and 6C illustrate an exemplary lens with at least three zones, including a light absorbing zone.

[0048] FIGS. 7A, 7B, 7C, 7D, 7E, and 7F illustrate exemplary steps in a process of manufacturing an exemplary lens.DETAILED DESCRIPTION

[0049] The disclosure is related to lenses, optionally vision correction lenses such as intraocular lenses, although concepts herein may find broader applicability, such as with controlling or creating one or more mechanical properties in polymeric materials in general.

[0050] The disclosure is related to lenses that have, as well as methods of creating, one or more desired mechanical properties in a portion of a lens, such as a non-optic peripheral portion. Non-optic peripheral portions herein may be referred to as haptic(s) and may optionally include one or more footplate regions of one or more haptics. As used herein, the term haptic can refer to one or more haptic structures, including one or more footplates.

[0051] In some examples but not limiting in any way, the lenses may be posterior chamber lenses, such as, without limitation, an Intraocular Collamer Lens. In some examples, thelenses may be intraocular lenses adapted for placement within a capsular bag after a native lens has been removed.

[0052] FIGS. 1A (top view), IB (side sectional view of the section in FIG. 1A) and 1C (highlighted view of a haptic region including one footplate) illustrate an exemplary lens 100, including optic 102, haptic (or haptic region) 104, wherein haptic 104 includes a plurality of footplates 106 (in this example, four footplates), each extending generally radially outward from adjacent haptic regions of first and second sides of the lens. Footplates 106 are positioned and configured to help stabilize the lens when implanted in the eye by engaging tissue and resisting lens rotation. As shown in FIG. IB and more specifically in FIG. 1C, footplates 106 are, in this example, at an angle “a” relative to adjacent haptic regions, which can help the footplates to have a preferential bending direction and preferentially bend in an anterior direction when implanted.

[0053] Lens 100, or any lens herein, may have a central body width 103 (measured along the axis “W” in FIG. 1 A) sized to cover pupil sizes up to 8 mm in scotopic conditions. In some non-limiting examples, the width 103 of any lens herein may be up to 8.5 mm.

[0054] Lens 100 may include any of the features described in US2016 / 0193037, which is fully incorporated by reference herein. While footplates 106 appear to have grooves or slits therein, this is intended to be representative of mechanical properties within haptic regions to provide one or more of the benefits herein, such as those related to sizing, stability and / or tissue damage mitigation. As stated above, although it may be preferable for footplates to have smooth surfaces that are free or substantially free of grooves, bends, slits or other nonsmooth features, footplates herein may include one or more non-smooth features and still be able to provide one or more of the benefits herein. Lens 100 also includes one or more apertures 108 extending through the lens from an anterior side of the lens to a posterior side of the lens, one of which extends through an optical axis through a center of the optic 102, as shown. In this example, the central aperture through the optical axis is smaller (e.g., smaller diameter) than apertures in the haptic region, as shown, although it may be larger or they may have the same size.

[0055] Footplates 106 in this example have a non-cylindrical or non-circular configuration or profile, which adds stability to footplates 106 and lens 100. In this example, footplates with a non-cylindrical configuration include a flat outer edge surface 107 (only one is labeled in FIG. 1 A) or a substantially flat outer edge surface. By comparison, footplates 506 in FIG.5 A include an outer edge surface with a cylindrical or circular configuration or profile, which may include a section with a constant or near-constant radius of curvature. Any of thefootplates herein may optionally have a configuration as in FIGS. 1 A or 5 A, while the footplates in FIG. lAmay enhance lens stability.

[0056] The lenses herein, including lens 100, may have preferred mechanical properties created within one or more portions within them utilizing application of controlled ionizing energy to the lens, where examples herein include applying or delivering controlled x-ray energy to the lens. Other types of ionizing energy may alternatively be used. Ionizing energy can be delivered to one or more regions of the lens in a controlled, focused manner to precise regions of the lens. In use, a polymeric material (which may or may not have optical surfaces formed therein) can be precisely irradiated with ionizing energy to break a desired amount of cross-linked bonds in or more regions. Controlled and precisely delivered x-ray energy can be delivered to one or more lens regions, which breaks at least some of the cross-linked bonds in the region. When the lens is subsequently hydrated (e.g., in balanced salt solution, BSS), the lens swells more and changes surface geometry (changes are proportional to absorbed dose ionization energy) in the regions where cross-linked bonds were broken compared to regions where the energy was not delivered, resulting in a greater degree of swelling, a decrease in stiffness (increase in softness), and optionally a change in height in those regions.

[0057] Lens 100 optionally includes iris interface rotational resist elements 130, examples and features of which are described in more detail below with respect to FIGS. 7A-7F herein. The side view of FIG. IB illustrates two different sizes of exemplary iris interface rotational resist elements 130, with one type including surface 130’ (solid line) and the other including surface 103” (dotted line). Surface 130’ is an example of a surface of an iris interface rotational resist element 130 that has at least a portion that is higher (in the anterior direction) than the anterior surface of the optic, and at least a portion of it is also the furthest anterior surface of the lens (in this example). Surface 130” is an example of a surface of an iris interface rotational resist element 130, no portion of which is higher than the anterior surface of the optic, and in this example the entirety of surface 130” is lower than the anterior surface of the optic. In alternatives, at least a portion of surface 130” may be at the same anterior “height” or level as the anterior surface of the optic. Any of the iris interface rotational resist elements 130 herein may thus include a portion that extends further anteriorly than the optic (e.g., surface 130’), to the same anterior extent as the optic, or lower than the anterior surface of the optic (e.g., surface 130”). In some examples, all of the optional iris interface rotational resist elements 130 have the same relative size (and same anterior “height”), but in other examples, one or more iris interface rotational resist elements 130 may have different sizes (e.g., anterior heights) than any other iris interface rotational resist element 130.

[0058] Methods herein may optionally include delivering ionizing energy with one or more of the following parameters: 5-1000 micron beam; x-ray photon energy in the range of 1-100 keV; absorbed dose of ionizing radiation of 1 kGy to 100 kGy (1 Gray = 1 Joule ionization energy per kilogram = 100 rad).

[0059] FIG. 2 illustrates an exemplary x-ray energy delivery apparatus 250, emitting energy 220 towards exemplary lens 200. In FIG. 2, energy 220 is delivered in a controlled and precise manner to one of the footplates 206 after at least one optical surface has been formed in lens 200. In other examples, energy can be applied to the body even if optical surfaces are not yet formed in the body, and even if the body is not being used as a lens.

[0060] Ionizing energy may be applied to create haptic regions that have non-uniform or uniform cross-link densities within the region to which energy is applied. As a result, upon hydration, the regions can have non-uniform or uniform mechanical properties in the region, respectively. In regions with non-uniform mechanical properties, the distribution may include multiple discrete zones that each have separate properties, a gradient of properties (gradual change) within the region, or any combination of the two. For example only, and with reference to FIG. 3, the two footplates 306 (two footplates are not shown) of lens 300 can have non-uniform mechanical properties within the footplate. In this example, stiffness will be used as an example of a mechanical property, although flexibility may similarly be used to describe the mechanical properties.

[0061] As an example, footplates 306 may optionally have discrete and different stiffnesses in each of zones 310, 312 and 314. For example only, the stiffness in zone 310 may be greater than the stiffness in zone 312, which can be greater than the stiffness in zone 314. This may be considered a decreasing stiffness in an outward direction. Optionally, stiffness in zone 310 may be the same or different (less or greater) as the stiffness in nonfootplate region of haptic 308, which is adjacent to zone 310 and closer to the optic than zone 310.

[0062] As an example, footplates 306 may have a gradient change in stiffness from zone 310 and zone 314, and may optionally be continuously changing (e.g., continuously decreasing from within zone 310 through zone 314; or continuously increasing in stiffness from zone 310 to zone 314).

[0063] In some examples, different footplates can have different distributions of mechanical properties. For example only, first and second footplates may have gradient, gradual variations in stiffness, while third and fourth footplates have a plurality of discrete zones of varying stiffness.

[0064] As an additional example, ionizing energy may be applied to footplates in a controlled manner such that the footplates have uniform mechanical properties throughout the entire footplate regions 306. The footplates may be softer than they would have been but for the application of ionizing energy but may have a uniform or substantially uniform stiffness.

[0065] As an additional example, one or more footplates may have non-uniform mechanical properties throughout, while one or more other footplates may have uniform mechanical properties throughout.

[0066] In any of the footplates herein with uniform or non-uniform cross link densities, the region can have a non-variable chemical composition.

[0067] By controlling the mechanical properties in the footplates using x-ray energy, the stiffness of the footplates, and optionally a varying stiffness throughout the footplates, can be controlled, to facilitate one or more of the sizing benefits and tissue damage mitigation benefits herein. For example, and in general, making the footplate less stiff, relative to a stiffness without the energy delivery process, the footplates have more deformability (can deform to a greater extent compared to footplates the same in all regards but which are not exposed to radiation) and fewer sized lenses may be needed to accommodate a variety of patient anatomies. When used as a posterior chamber lens, a greater degree of flexibility may allow a single lens to be implanted into a larger patient, while the same lens may be placed into a smaller patient with the footplates flexing as needed to accommodate the patient size and without losing centration of the lens. Additionally, the greater deformability can allow the footplates to more reliably and consistently deform into a cavity between a posterior chamber lens (e.g., an ICL) and iris, one area of which is highlighted with dotted lines in the sectional imaging view shown in FIG. 4. Additionally, and as shown in FIG. IB, the general angulation in the anterior direction, coupled with the softness, may facilitate even more reliable deformability into the cavity shown in FIG. 4, which also prevents the footplate from buckling under the native capsule. Additionally, the deformability of the footplates due to increased softness and flexibility can prevent or minimize lens contact with the capsular bag / natural lens (or at least apply less force thereto) to prevent complications such as increased risk of cataracts and glaucoma.

[0068] Additionally, for example, and in general, making the footplate less stiff (more flexible), relative to a stiffness without the energy delivery process, the softer footplates are less likely to damage adjacent tissue, thus mitigating the risk of tissue damage. For example, the relatively softer footplates can cause less damage to zonules, the sulcus and capsular bag when the lens is implanted. Some posterior chamber lenses (e.g., ICL’s) footplates rest on the zonules / sulcus, and damage to the zonules is highly undesirable.

[0069] Approaches herein are described that can be used to create smooth footplates that still have desired mechanical property and flexibility, compared with previous approaches that may have relied on grooves, slits or other geometrical changes to accomplish footplate bending. It is possible, however, that soft, smooth footplates created using methods herein may include one or more non-smooth features (e.g., grooves). There are situations, however, when it is or likely beneficial to minimize or avoid any buckles / grooves to reduce damage to tissue and thus having desired mechanical properties while having the option of smooth footplate surfaces may be highly beneficial and perhaps even necessary.

[0070] While footplates herein may help resist lens rotation in the eye (increase rotational stability) once implanted via the zonules, the lenses may additionally or alternatively have one or more one or more iris interface rotational resist elements (for example without limitation, any of the legs / rails herein), which may have mechanical properties, are sized configured and adapted to help resist lens rotation upon interaction with the iris. Features of any of the iris rotational resist elements herein may be combined with any other feature of any of the other iris rotational resist elements herein. For example, all disclosures related to FIGS. 1 A and IB can be combined / incorporated with any disclosure from FIGS. 5A-5G.

[0071] FIG. 5A illustrates lens 700 that includes a plurality of exemplary iris interface rotational resist elements that are sized, configured and positioned to engage iris tissue and help resist lens rotation, while also being adapted to mitigate damage to the iris. In this example, lens 700 includes footplates that may or may not include any of the features described in any other lens shown or described herein, all of which are fully incorporated into the disclosure of lens 700. Lens 700 includes a plurality of exemplary iris interface rotational resist elements 730, in this example two on each of first and second sides of the lens (the sides generally separated by the dashed axis as shown), and both on and / or part of the anterior surface of lens 700. In this example, during manufacturing, energy (e.g., x-ray) is applied to haptic regions 730, and following hydration of the lens, the regions 730 that absorbed energy (cross-linked bonds broken) swell more than adjacent lens areas, as described herein, and become raised and relatively less stiff (more deformable) regions 730 (greater height relative to adjacent haptic surfaces), helping minimize the gap between the iris and the anterior surface of the posterior chamber lens. When implanted, iris interface rotational resist elements 730 are, in this example, positioned, configured and sized to contact the iris symmetrically about the lens central axis and help resist lens rotation based at least partially on the engagement between the elements 730 and the iris.

[0072] Iris interface rotational resist elements 730 can also act as iris damage mitigating elements since they are relatively softer with at least some additional deformability uponhydration, causing less damage to the iris upon contact. In this case, they may be referred to as iris damage mitigating elements.

[0073] Iris interface rotational resist elements 730 may have a wide variety of configurations, and those shown in FIG. 5A are examples of elongate rails or arms (similar to sled rails). They may have varying widths along their lengths. For example, FIG. 5B illustrates a top view of an exemplary lens 700B including optic 702B and haptic 704B, and which may include any one or more features of any lens herein. Lens 700B includes iris interface rotational resist elements 730B, each of which is oriented at an angle, in this case Beta (“P”) relative to a horizontal axis passing through the optical axis (which as shown, optionally includes any of the central apertures herein). In any of the lenses herein, an angle Beta may be from 1 degree to 80 degrees, for example, such as from 10 degrees to 60 degrees. The angulation of the elements 730B may be more naturally aligned with the radial dilation and constriction motion of the iris (referred to herein as “iris movement”) since the iris in humans is a round muscle. For example, iris movement may be less restricted by elements 730B compared to, for example, elements 130 and 730 shown in FIGS. 1A and 7 A, respectively. This is not to suggest elements 130 and 730 do not provide lens stability benefits, simply that they may be slightly more restrictive, which in some applications may actually be desirable. Additionally, lens 700B includes pair of elements 730B that are optionally co-axial or co-linear, as shown in FIG. 7B with pairs being aligned on the same dotted lines, as shown.

[0074] FIG. 5C illustrates an alternative lens 700C that comprises optic 702C and haptic 704C. Lens 700C includes iris interface rotational resist elements 730C, which include pairs of parallel elements 730C, similar to those shown in FIGS. 1 A and 7 A, whereas the elements 730C in each pair are closer together. Elements 730C may alternatively have some degree of angulation “Beta” to them, illustrated in FIG. 7B, such that the pairs are not parallel.

[0075] FIG. 5D illustrates an alternative lens 700D including optic 702D and haptic 704D with iris interface rotational resist elements 730D. In this example, each element 730D has a greater width dimension (top-to-bottom in the figure) relative to iris interface rotational resist elements in FIGS. 7A-7C, and only a single pair of co-axial or co-linear elements, one on each lateral side of the lens, is shown. In this example, the rotational stability may be provided by the larger surface area of the iris contacting surfaces of the elements 730D. Elements 730D are also examples of iris interface rotational resist elements that include apertures therethrough for fluid flow.

[0076] FIGS. 5E and 5Ee illustrate an alternative lens 700E including optic 702E and haptic 704E with, in this example, two iris interface rotational resist elements 730E. In thisexample, elements 730E have a variable width dimension along the lengths, and which in this example are wider at one radial distance / location 751 compared to a second radial distance / location 753. In this example, location 751 is radially closer to an optical axis of the optic than location 753, such that a general triangular shape is pointed or directed radially outward. Elements 73 OE may understandably have other shapes, such as, for example without limitation, raindrop configurations that generally “point” radially outward. Without being limiting, the wider dimension at the radially inner location 751 may be beneficial if contact / compression from the iris tissue is greater at location 751 than at relatively more radial location 753, which is further radially outward. If the compression / contact from iris at location 753 is not as great, there may be less need to have as much surface area of element 730E at that location. Additionally, without wishing to be limiting, there may be advantages to minimizing the volume of the softer more swollen elements in general, such as minimizing overall lens volume for insertion through a delivery device. Elements 730E are examples of iris interface rotational resist elements configured, sized and positioned to provide stability and minimize iris damage while also considering volume and avoiding potentially unneeded volume in certain portions of the elements 73 OE at locations where additional surface area / volume may not be needed. Elements 73 OE may alternatively have some angulation angle Beta illustrated in FIG. 7B. Additionally, lens 700E may alternatively have pairs of elements 730E at angles Beta, wherein the elements in a pair may be co-linear (co-axial) as illustrated in FIG. 7B.

[0077] FIG. 5F illustrates an alternative lens 700F including optic 702F and haptic 704F with, in this example, two iris interface rotational resist elements 730F. Elements 730F are similar to elements 730D, but have more rounded surfaces than elements 730D. Elements 730F may alternatively have some angulation Beta illustrated in FIG. 7B. Additionally, lens 700F may alternatively have pairs of elements 730F at angles Beta, wherein the elements in a pair may be co-linear (co-axial) as illustrated in FIG. 7B.

[0078] FIG. 5G illustrates with dotted lines exemplary pupil sizes in photopic (daytime; inner dotted line) and scotopic (low light) conditions (outer dotted line), respectively, relative to exemplary lens 700G.

[0079] Any of the iris interface elements herein (for rotational stability and / or minimizing iris damage) may be adapted to deform to some extent when they contact iris tissue. Controlling cross-linking as described herein can be used to control the stiffness or deformability in different regions of the iris interface elements, such as making it more deformable where it will engage iris tissue but relatively stiffer at other locations.

[0080] Additionally, any of the iris interface elements herein may have variable stiffness along at least a portion of the element. For example only, iris interface elements 730E may be softer (less stiff) in location 751 than at location 753, which facilitates greater deformability at location 751 than at 753.

[0081] In alternative designs, any of the iris interface rotational resist elements (e.g., elements 730) may be raised regions machined into the anterior surface rather than formed upon swelling with hydrating fluid after being exposed to ionizing energy. These alternative designs may not provide a benefit of additional relative softness or deformability, but they may still provide increased rotational lens stability relative to a lens without the raised iris interface rotational resist elements.

[0082] FIGS. 5H, 51, 5J and 5K illustrate an alternative lens 700H (with optic 702H and haptic region 704H) and at least part of a method of manufacturing lens 700H. In an exemplary method of manufacturing, recessed grooves or channels 751 are machined into anterior surface of lens 700H in haptic region 704H, with a first portion radially closer to optic 702H than a second radially outer portion. In this example, machined recessed grooves 751 are elongate, but they may have other configurations or shapes. FIG. 51 shows Section A- A from FIG. 5H, including two of the formed recessed grooves 751, which may be formed using a variety of machining processes. Forming grooves 751 creates an unmachined region of haptic body 752 (in this example, elongate) between grooves 751, as shown.

[0083] As represented in FIG. 5 J, after grooves 751 are formed into the body, ionizing energy 753 is applied to regions 752 in between the grooves to break cross-linked bonds in regions 752, as described herein including materials incorporated by reference. Any of the methods of applying controlled ionizing energy to break at least some of the cross-linked bonds herein may be used (e.g., x-ray energy) to precisely deliver energy to regions 752.

[0084] After controlled ionizing energy 753 is applied or delivered to region 752 to break at least some of the cross-linked bonds, and upon swelling thereof with exposure to hydrating fluid, regions 752 swell and increase in volume to create raised regions 754 of increased height, as shown in FIG. 5K.

[0085] After swelling, relatively softer raised regions 754 extend further in the anterior direction than the anterior surface of the optic, as shown relative to the dashed line in FIG. 5K. As described above, raised regions 754 are relatively softer or less stiff than adjacent regions of the lens body, which can provide the iris damage mitigating benefits described herein. In this example, grooves 751 are recessed (in the posterior direction) relative to immediately adjacent haptic regions, including relative to raised regions 754.

[0086] The thickness measured in the anterior-to-posterior direction (between anterior and posterior surfaces) of grooves 751 is, even before the swelling of regions 752, less than immediately adjacent haptic region including the thickness of irradiated regions 752, as shown in FIG. 51. This creates relatively thin, optionally membrane-like regions on both sides of each of the irradiated regions 752, that upon swelling of regions 752, may reduce stress in the haptic regions 751 as region 752 swells to form the raised regions 754. Without wishing to be limiting, lenses that include the relatively thinner stress reducing grooves 751 may optionally, depending on the application, be preferred to some lenses herein that do not include one or more recessed grooves formed therein, such as lens 100. For example only and not limiting in any way, there may be some relatively small stresses on the haptic body adjacent to regions 130 during swelling, which may, depending on the application, be less than optimal. For example only, some minor stresses in the haptic region may (but not necessarily) impact the adjacent optic region and interfere with the quality of the vision correction.

[0087] In some examples, grooves 751 may be cut to a depth of at least 25% of the thickness of the lens body at the location of the groove and up to 95% of the thickness, or at least 30%, or at least 35%, or at least 40%, or at least 50%. In these examples, the grooves are not cut all the way through the haptic such that there is some thickness to the grooves, measured in the anterior to posterior direction.

[0088] The depth of the grooves may help control the swell factors and / or stresses in adjacent haptic regions due to swelling.

[0089] Any lens herein may include both footplates with controlled mechanical properties as is described herein, as well as iris interface rotational resist elements, or only one or the other.

[0090] While some lenses herein include iris interface rotational resist elements (e.g., elements 730) that include raised regions of the lens, lenses herein may alternatively or additionally include one or more rotational resist elements that are grooves, channels, or recesses formed in the anterior surface of the haptic region and that are positioned and configured to help stabilize the lens. FIGS. 5L, 5M and 5N illustrate an exemplary lens 700L (with optic 702L and haptic region 704L). In an exemplary method of manufacturing, recessed grooves, recesses or channels 760 are machined into anterior surface of lens 700L in haptic region 704L. In this example, machined recessed grooves 760 are elongate and extend radially outward, but they may have other configurations / shapes. FIG. 5M shows Section A- A from FIG. 5L, including one of the formed recessed grooves 760, which may be formed using a variety of machining processes. FIG. 5N illustrates a close-up view of groove 760,showing it includes a depressed surface 761, a depth D, and a width W. While not labeled, grooves 760 also have a length measured along their radial dimension.

[0091] Grooves 760 have a depressed or recessed surface 761, and after the lens is implanted, the groove causes a portion of the iris that is adjacent to the grooves 760 to enter or at least partially fill the open space or volume of the groove, creating an interface between the iris tissue and the groove surface 761 and increasing rotational stability of the lens. The iris can be thought of as plugging up the space of the grooves 760, creating an interface and helping rotationally stabilize the lens. The depth, width and length of the groove(s) may be modified as needed to obtain desired rotational stability of the lens. For example (if the groove optionally has a constant or uniform depth), a very shallow groove may not create sufficient rotational stability, while a groove too deep could potentially cause complications such as iris damage. Following implantation, the interface between a groove and iris may cause the formation of a callus / tyloma on the iris where it interfaces the groove, optionally further enhancing rotational stability of the lens.

[0092] Any of the grooves and / or raised regions (e.g., rails) may have a thickness or depth dimension that is not constant or uniform along the radial length of the groove / rail. For example only, any of the grooves and / or raised regions herein may have a gradually changing depth / thickness along its length. For example only, any of the grooves and / or raised regions herein may have a stepwise or discrete variation in thickness / depth along at least a portion of its radial length. For example only, any of the grooves and / or raised regions herein may have any other non-constant depth / thickness, such as an elliptically shaped depth / thickness along its radial length. Alternatively, any of the grooves and / or raised regions (e.g., rails) may have a thickness or depth dimension that is constant or uniform along the radial length of the groove / rail.

[0093] In this example, grooves 760 are colinear, and aligned with the optical axis of the optic 702L, as shown. The depth “D” of any of the grooves herein is optionally from 15 - 150 microns. The width “W” of any of the grooves herein is optionally from 15 - 150 microns.

[0094] In some examples, grooves 760 may be cut to a depth of at least 5% of the thickness of the lens body at the location of the groove and up to 95% of the thickness, In these examples, the grooves 760 are not cut all the way through the haptic such that there is some thickness to the grooves (in the anterior to posterior direction).

[0095] FIG. 50 illustrates an alternative lens that includes a plurality of grooves 760’, which may include any feature of grooves 760. As shown, pairs of grooves 760’ are colinear and at an angle (as shown in FIG. 5B). Grooves formed in the haptic regions may be situated in any position or relative position as desired or necessary for rotational stability and / or tissuedamage mitigation (e.g., first and second grooves may be parallel, while third and fourth grooves may be angulated with respect to each other and / or with respect to an optical axis). For example, all grooves or raised regions on each side of the lens may be parallel or angulated with respect to each other.

[0096] FIGS. 5P and 5Q illustrate an alternative lens 700P that includes a plurality of grooves 780, which are similar to grooves 760 and 760’ and configured to increase rotational stability. In this example, there are a plurality of grooves 780 on first and second sides of the lens, and the grooves 780 also extend into the optic region 702P, as well as the haptic region 704P. FIG. 5Q shows the section taken through the lens in FIG. 5P. In this example, the grooves on each side of the lens are all parallel and are colinear with a groove on the other side of the lens, as shown. Any of the features of grooves 780 may be the same as any of the features of grooves 760 or 760’ (such as dimensions).

[0097] FIG. 5R shows an alternative to lens 700P with grooves 780’, wherein two sets of three grooves on either side of the lens are angulated (see FIG. 7B), wherein each groove within each set is angulated with respect to the other grooves in the set on that side of the lens. Additionally, pairs of grooves 780’ including first and second grooves on opposite sides of the lens (the other side) are optionally colinear with each other, as shown.

[0098] Any of the grooves and / or raised regions herein may be parallel with any other groove and / or raised region herein (e.g., FIGS. 5C, 5H, 5P). For example, grooves and / or raised regions on each side may be parallel with each other (e.g., FIGS. 5C, 5H, 5P).

[0099] Any of the grooves and / or raised regions herein may be angulated, including being angulated relative to any other groove and / or raised region herein (e.g., FIGS. 5B, 50, 5R). For example, grooves and / or raised regions on each side may be angulated relative to each other (e g., FIGS. 5B, 50, 5R).

[0100] Any of the lenses with grooves (such as grooves 760, 760’) may also include any of the raised iris stability elements herein, such as any of the raised elements in FIGS. SASK).

[0101] Lenses herein may optionally include a light absorbing region outside of the optic, and in this regard, the entirety of PCT publication W02023 / 060017 is incorporated by reference herein for all purposes. For example only, light absorbing regions / materials, and transparent materials are incorporated by reference herein, and may be used in haptic regions and optic regions of the lenses herein. Some lenses herein, however, may be different than lenses in W02023 / 060017 in that an outer haptic region, optionally, including footplates, include a transparent material, exemplary benefits of which are described herein.

[0102] FIGS. 6A, 6B and 6C illustrate an exemplary lens 500 that includes transparent optic 502, light absorbing haptic region 508, and an outer transparent haptic region 505, including transparent footplates 506. Any of the mechanical properties described (e.g., stiffness) for any of the benefits provided herein (sizing, tissue damage mitigation) may be incorporated into lens 500.

[0103] There are a variety of non-limiting reasons why it may be beneficial for the lens to include transparent footplates (rather than including light absorbing material in the footplates). For example, to program and control the thickness of the footplates it may be necessary to optically measure (e.g., with an interferometer) the thickness of the footplates as a part of the manufacturing process, and a light absorbing material in the footplates can interfere with optical measurements. In general, the footplates may need to be very thin, and measuring the thickness may be critical depending on the type of lens.

[0104] Additionally, it may be beneficial for the lens to include transparent footplates (rather than including light absorbing material in the footplates) to avoid having possibly abrasive or relatively stiffer light absorbing components in the footplates to mitigate tissue damage and avoid high stiffness. As stated herein, it may be essential to avoid or mitigate the risk of damage to zonules and / or the sulcus.

[0105] Lens 500 includes a transparent optic 502, transparent haptic region 505 (including footplates 506), and a non-transparent region 508 in between. In alternative examples, the haptic region 505 (including footplates 506) may also be non-transparent. Optic 502 and haptic region 505 may optionally comprise a grafted collagen acrylic co-polymer, and which may be the same formulation or different formulations. Non-transparent region 508 may comprise a grafted collagen black acrylic co-polymer, having a formulation different than optic 502 and haptic region 508. The material for the footplates cannot be so hard that it cuts through zonules. The material in haptic region 505 may be homogenous.

[0106] One aspect of the disclosure herein is related to methods of manufacturing any of the lenses herein. FIGS. 7A, 7B, 7C, 7D, 7E, and 7F illustrate a portion of exemplary manufacturing steps that may occur when making lens 500 or other similar lenses. Method steps in W02023 / 060017 are fully incorporated by reference herein. A transparent rod may be placed within a lumen or channel of a non-transparent cylinder (tube), as shown in FIG. 7C. That assembly may then be placed in a larger lumen of a larger transparent cylindrical rod, as shown in FIGS. 7D and 7E (fully cured in FIG. 7E). Buttons can then be created from the assembled three-material rod (illustrated in FIG. 7F), into which one or more optical surfaces may be formed. Ionizing energy may then be applied to one or more haptic regions (e.g., see FIG. 2) to break at least some of the cross-link bonds, followed by hydration (e.g.,BSS) to cause swelling of the material in the regions exposed to energy. Alternatively, a first polymerization step may occur at FIG. 7C (to bond the inner and intermediate materials), and a second polymerization step may occur at FIG. 7D to bond the intermediate and outer materials.

[0107] Any feature of any embodiment, example, claim, figure, or other part of this disclosure may be integrated with any other suitable combinable feature of any embodiment, example, claim, figure, or other part of this disclosure, unless indicated to the contrary herein.

[0108] Any of the iris interface rotational resist elements herein may be more generally referred to herein as any of anterior surface elements herein. Any of the iris damage resist elements herein may be more generally referred to herein as any of the anterior surface elements herein.

[0109] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Furthermore, it should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein and may be used to achieve the benefits described herein.

[0110] This application incorporates by reference the following publications, the full disclosures of which are incorporated by reference herein in their entireties for all purposes: W02020 / 037314, US 2020 / 0071440, and W02023 / 060017.[OHl] When a feature or element is herein referred to as being "on" another feature or element, it can be directly on the other feature or element or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.

[0112] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and / or "comprising," when used in this specification, specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ".

[0113] Spatially relative terms, such as "under", "below", "lower", "over", "upper" and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as "under”, or "beneath" other elements or features would then be oriented "over" the other elements or features. Thus, the exemplary term "under" can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms "upwardly", "downwardly", "vertical", "horizontal" and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

[0114] Although the terms “first” and “second” may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Thus, a first feature / element discussed below could be termed a second feature / element, and similarly, a second feature / element discussed below could be termed a first feature / element without departing from the teachings of the present invention.

[0115] In general, any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and / or steps may alternatively be exclusive and may be expressed as “consisting of’ or alternatively “consisting essentially of’ the various components, steps, sub-components or sub-steps.

[0116] “An embodiment,” “in an embodiment”, “in another embodiment,” “embodiments,” “certain embodiments,” or “in some embodiments” each has the meaning herein of “in one or more embodiments”. Similarly, “a configuration,” “in a configuration,”in one configuration,” “in another configuration,” “configurations,” “certain configurations,” or “in some configurations” each has the meaning herein of “in one or more configurations.”

[0117] The terms “e.g.,” “such as,” “for example,” “and so forth,” and “etc.” mean that what follows the “e.g.,” “such as,” or “for example” or what precedes the “etc.” or “and so forth,” is a list of examples and there may be other items that could also serve as examples but are not listed.

[0118] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word "about" or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and / or position to indicate that the value and / or position described is within a reasonable expected range of values and / or positions. For example, a numeric value may have a value that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value " 10" is disclosed, then "about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that "less than or equal to" the value, "greater than or equal to the value" and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value "X" is disclosed the "less than or equal to X" as well as "greater than or equal to X" (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0119] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, theforegoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.

[0120] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

Claims

CLAIMS1. A lens sized and configured to interface with a sulcus of an eye, the lens comprising: an optic region; and a haptic region outside of the optic region and having a uniform chemical composition, the haptic region having a non-uniform cross-link density imparting at least one non-uniform mechanical property within the haptic region.

2. The lens of claim 1, wherein the haptic region comprises at least one haptic footplate.

3. The lens of claim 2, wherein the haptic region comprises a plurality of haptic footplates, each of which has a non-uniform cross-link density that imparts at least one non- uniform mechanical property to each of the plurality of haptic footplates when hydrated.

4. The lens of claim 1, wherein the haptic region forms a peripheral edge of the haptic region.

5. The lens of claim 4, wherein the haptic region does not comprise a haptic footplate.

6. The lens of claim 1, wherein the haptic region includes a first region with a first crosslink density and a first stiffness when hydrated and a second region with a second cross-link density and a second stiffness when hydrated, the first cross-link density less than the second cross link density and the first stiffness less than the second stiffness.

7. The lens of claim 6, wherein the first region is closer to a haptic region peripheral edge than the second region.

8. The lens of claim 7, wherein the first region forms a peripheral edge of the haptic region.

9. The lens of claim 8, further comprising a bend in the haptic region at an interface between the first region and the second region.

10. The lens of claim 6, wherein the second region is closer to a haptic peripheral edge than the first region.

11. The lens of claim 10, further comprising a bend in the haptic region at the interface between the first region and the second region.

12. The lens of claim 1, wherein the haptic region has a gradient variation in stiffness.

13. The lens of claim 12, wherein the gradient variation in stiffness comprises a gradient in which the stiffness gradually decreases outward in a direction toward a peripheral edge of the haptic region.

14. The lens of claim 12, wherein the gradient variation in stiffness comprises a gradient in which the stiffness gradually increases in a direction toward a peripheral edge of the haptic region.

15. The lens of claim 12, wherein the gradient variation in stiffness comprises a gradient in only a portion of the haptic region.

16. The lens of claim 12, wherein the gradient variation in stiffness comprises a gradient variation throughout an entirety of the haptic region.

17. The lens of claim 1, wherein the at least one non-uniform mechanical property of the haptic region is created when the haptic region is hydrated in balanced salt solution (“BSS”).

18. The lens of claim 1, wherein the at least one non-uniform mechanical property of the haptic region comprises a non-constant stiffness in the haptic region.

19. The lens of claim 1, wherein the haptic region is void of a groove.

20. The lens of claim 19, wherein the haptic region has a variable thickness.

21. The lens of claim 20, wherein the variable thickness comprises a gradual change in thickness.

22. The lens of claim 1, wherein the haptic region includes at least one groove therein, the groove formed by an abrupt change in thickness.

23. The lens of claim 1, wherein the at least one non-uniform mechanical property is adapted to reduce an amount of lens vaulting when placed in the sulcus compared to a comparable lens that is the same in all respects, but which excludes the at least one non- uniform mechanical property.

24. The lens of claim 1, wherein the haptic region is angled anteriorly relative to an adjacent haptic region.

25. The lens of claim 1, wherein the haptic region comprises a first chemical composition and an adjacent haptic region comprises a second chemical composition.

26. The lens of claim 25, wherein the first chemical composition is the same as the second chemical composition.

27. The lens of claim 25, wherein the first chemical composition is different than the second chemical composition.

28. The lens of claim 27, wherein the adjacent haptic region is black.

29. The lens of claim 27, wherein the adjacent haptic region is adapted to absorb light.

30. The lens of claim 29, wherein the haptic region is transparent.

31. The lens of claim 30, wherein the first chemical composition is a collagen copolymer and the second chemical composition is a collagen copolymer.

32. The lens of claim 25, wherein the first chemical composition is a collagen copolymer.

33. The lens of claim 32, wherein the second chemical composition is a collagen copolymer.

34. The lens of the claim 25, wherein the first chemical composition is the same composition as the optic region.

35. The lens of the claim 25, wherein the first chemical composition is different than an optic chemical composition of the optic region.

36. The lens of claim 1, wherein the optic region and the haptic region are transparent and are separated by a second haptic region adapted to absorb light.

37. A lens sized and configured to interface with a portion of an eye when implanted into the eye, the lens comprising: an optic body and a haptic, the haptic comprising a footplate having a stiffness less than an adjacent haptic region, the footplate having uniform stiffness, and wherein a cross-link density in the footplate is less than a cross-link density in the adjacent haptic region.

38. The lens of claim 37, wherein a change in stiffness between the adjacent haptic region and the footplate creates a preferential bending location at which the footplate is adapted to bend relative to the adjacent haptic region.

39. The lens of claim 37 or claim 38, further comprising any one or more features or limitations of any one of claims 1-36.

40. A lens sized and configured to interface with a portion of an eye when implanted into the eye, the lens comprising: a haptic body that has a non-uniform cross-link density within at least a portion of the haptic body, the non-uniform cross-link density imparting at least one non-uniform mechanical property in the portion of the haptic body when hydrated.

41. The lens of claim 40, further comprising any other one or more features from claims 1-39.

42. An intraocular lens, comprising: a transparent optic comprising a first formulation; and a haptic including first and second regions,the first region non-transparent and outside of the transparent optic, and made of a second formulation, and the second region is transparent and made of a third formulation, the second region extending further radially than at least a portion of the first region.

43. The lens of claim 42, wherein the second formulation is different than the third formulation.

44. The lens of claim 42, wherein the transparent optic comprises a collagen acrylic copolymer and the second region is made of a collagen acrylic co-polymer.

45. The lens of claim 42, wherein the first region of the haptic comprises a collagen acrylic co-polymer.

46. The lens of claim 42, wherein the transparent optic, the first region and the second region have different stiffnesses.

47. A method of manufacturing an ophthalmic lens, the method comprising: positioning an optic rod within a cylindrical channel in a first tubular member, the optic rod made of transparent optic material and the first tubular member made of a visible light absorbing material; positioning the first tubular member within a cylindrical channel in a second tubular member, the second tubular member made of a transparent material; and securing the optic rod to the first tubular member and securing the first tubular member to the second tubular member.

48. The method of claim 47, wherein the positioning steps positions the optic rod, the first tubular member, and the second tubular member to be co-axial with each other.

49. The method of claim 47, further comprising, creating a button that includes a portion of the optic rod, a portion of the first tubular member, and a portion of the second tubular member.

50. The method of claim 49, further comprising machining optical surfaces in the portion of the optic rod, and machining non-optical surfaces in the portion of the first tubular member and the portion of the second tubular member, thereby creating an optic body and a haptic of the ophthalmic lens.

51. The method of claim 50, further comprising irradiating at least a portion of the haptic to break at least some cross-link bonds in the haptic.

52. The method of claim 51, further comprising hydrating the haptic and thereby decreasing a stiffness of at least the irradiated portion of the haptic.

53. The method of claim 51, wherein irradiating creates a gradient cross-link density in the irradiated portion of the haptic.

54. The method of claim 51, wherein irradiating comprises breaking cross-link bonds in two or more different regions such that the two or more different regions each have different cross-link densities.

55. The method of claim 51, wherein irradiating comprises breaking cross-link bonds uniformly throughout the portion of the haptic.

56. The method of claim 51, wherein irradiating comprises breaking cross-link bonds in at least a portion of one or more footplates of the haptic.

57. The method of claim 51, wherein the irradiating comprises breaking cross-link bonds only in a plurality of footplates of the haptic.

58. The method of claim 47, wherein positioning the optic rod within the cylindrical channel in the first tubular member occurs at a time prior to positioning the first tubular member within the cylindrical channel in the second tubular member.

59. The method of claim 47, wherein positioning the optic rod within the cylindrical channel in the first tubular member occurs at a time subsequent to positioning the first tubular member within the cylindrical channel in the second tubular member.

60. The method of claim 47, further comprising, creating a button that includes a portion of the optic rod, a portion of the first tubular member, and a portion of the second tubular member, and irradiating at least one of the portion of the first tubular member or the portion of the second tubular member to break at least some cross-link bonds.

61. The method of claim 60, further comprising machining at least one surface in the button to create a lens body comprising an optic and a haptic.

62. The method of claim 61, further comprising hydrating the lens body to modify at least one mechanical property of at least a portion of the haptic.

63. A method for modifying at least one mechanical property of a haptic region of a lens, the method comprising: in a cured haptic region of a lens, irradiating at least a portion of the cured haptic region with ionizing energy to break at least some cross-link bonds in the haptic region.

64. The method of claim 63, wherein the ionizing energy comprises X-rays.

65. The method of claim 63, further comprising hydrating the haptic region to modify at least one mechanical property of at least a portion of the haptic region, optionally hydrating in balanced salt solution.

66. The method of claim 65 wherein hydrating the haptic region decreases a stiffness of at least a portion of the haptic region.

67. The method of claim 63, wherein irradiating comprises breaking cross-link bonds in a gradient pattern to create a gradient cross-link density.

68. The method of claim 63, wherein irradiating comprises breaking cross-link bonds in two or more different haptic regions such that the two or more different haptic regions each have different cross link densities.

69. The method of claim 63, wherein the irradiating comprises breaking cross-link bonds uniformly throughout the portion of the cured haptic region, optionally uniformly throughout an entire portion of the cured haptic region.

70. The method of claim 63, wherein the irradiating comprises breaking cross-link bonds in at least a portion of one or more footplates of the haptic region.

71. The method of claim 63, wherein irradiating comprises breaking cross-link bonds only in footplates of the haptic region.

72. The method of claim 63, wherein irradiating comprises maintaining the haptic region in a stationary position, and wherein irradiating comprises moving an ionizing energy source in at least one direction.

73. The method of claim 63, wherein irradiating comprises maintaining an ionizing energy source in a stationary position and moving the haptic region in at least one direction during while irradiating at least the portion of the cured haptic region with ionizing energy.

74. The method of claim 63, wherein the haptic region comprises a collagen copolymer.

75. The method of claim 63, wherein irradiating includes irradiating an anterior surface of the haptic region, optionally as part of creating a plurality of iris interface rotational resist elements that are configured to add rotational stability to the lens.

76. A lens of any one of claims 1-46, wherein the lens includes a plurality of footplates with non-cylindrical configurations, optionally each including a flat or substantially flat outer edge surface.

77. A lens comprising, an optic; and a haptic sized and configured to interface with a sulcus of an eye, the haptic comprising an anterior surface that includes a plurality of iris interface rotational resist elements.

78. The lens of claim 77, wherein each of the plurality of iris interface rotational resist elements extend further anteriorly than adjacent haptic regions.

79. The lens of claim 77, wherein each of the plurality of iris interface rotational resist elements extend further anteriorly than an anterior surface of the optic.

80. The lens of claim 77, wherein each of the plurality of iris interface rotational resist elements do not extend further anteriorly than an anterior surface of the optic.

81. The lens of claim 77, wherein the plurality of iris interface rotational resist elements are each entirely below an anterior surface of the optic.

82. The lens of claim 77, wherein one of the plurality of iris interface rotational resist elements has a different size than one or more other iris interface rotational resist elements.

83. The lens of claim 77, wherein all of the plurality of iris interface rotational resist elements have the same size and configuration.

84. The lens of claim 77, wherein pairs of the plurality of iris interface rotational resist elements are parallel.

85. The lens of claim 77, wherein pairs of the plurality of iris interface rotational resist elements are not parallel.

86. The lens of claim 77, wherein first and second iris interface rotational resist elements are co-linear.

87. The lens of claim 86, wherein third and fourth iris interface rotational resist elements are co-linear.

88. The lens of claim 77, wherein first and second iris interface rotational resist elements are aligned and at an angle relative to a horizontal axis passing through an optical axis, and wherein third and fourth iris interface rotational resist elements are aligned and at the angle relative to the horizontal axis.

89. The lens of claim 77, wherein at least one iris interface rotational resist element of the plurality has a non-uniform width along a length of the element.

90. The lens of claim 89, wherein the at least one iris interface rotational resist element of the plurality has a width at a radially inner location greater than a width at a radially outer location.

91. The lens of claim 77, wherein at least one iris interface rotational resist element of the plurality has a non-uniform stiffness along a length of the iris interface rotational resist element.

92. The lens of claim 91, wherein the at least one iris interface rotational resist element of the plurality has a stiffness at a radially inner location that is greater than a stiffness at a radially outer location.

93. The lens of claim 91, wherein the at least one iris interface rotational resist element of the plurality has a stiffness at a radially outer location that is greater than a stiffness at a radially inner location.

94. The lens of claim 77, wherein at least one iris interface rotational resist element of the plurality is a recessed region, relative to an adjacent haptic region, in the anterior surface.

95. The lens of claim 94, wherein the recessed region has an elongate configuration.

96. The lens of claim 94, wherein the recessed region has a depth from 15 - 150 microns.

97. The lens of claim 94, wherein the recessed region has a width from 15 - 150 microns.

98. The lens of claim 94, wherein the recessed region has a depth from 5% to 95% of a thickness of the adjacent haptic region.

99. A lens sized and configured to interface with a sulcus of an eye, the lens comprising: an optic body; and a haptic with a plurality of footplates, each of the plurality of footplates extending further outward relative to adjacent haptic region, each of the plurality offootplates having less cross-link density than a haptic region that is closer to the optic body.

100. The lens of claim 99, wherein each of the footplates has a non-uniform cross-link density.

101. The lens of claim 99, wherein each of the footplates has a non-uniform cross-link density.

102. A method for modifying at least one mechanical property of a haptic region of a lens, the method comprising: in a cured haptic region of a lens body, irradiating a plurality of discrete regions of the haptic region with ionizing energy to break at least some cross-link bonds in the discrete regions, each of the plurality of discrete regions comprising an anterior surface of the haptic region and spaced apart from each of the other plurality of discrete regions.

103. The method of claim 102, further comprising hydrating the lens body, causing the plurality of discrete regions to become raised in an anterior direction relative to adjacent haptic regions.

104. The method of claim 102, wherein irradiating comprises irradiating first and second discrete regions that are parallel.

105. The method of claim 102, wherein irradiating comprises irradiating first and second discrete regions that are not parallel.

106. The method of claim 102, wherein irradiating comprises irradiating first and second discrete regions that are co-linear and on opposite sides of the lens body.

107. A lens comprising, an optic; and a haptic sized and configured to interface with a sulcus of an eye, the haptic comprising an anterior surface that includes a plurality of iris interface rotational resist elements, each of the plurality of iris interface rotational resistelements are raised regions that extend further anteriorly than adjacent haptic regions, and which are spaced apart from each other.

108. A lens comprising, an optic; and a haptic sized and configured to interface with a sulcus of an eye, the haptic comprising an anterior surface that includes a plurality of iris damage resist elements, each of the plurality of iris damage resist elements are raised regions that extend further anteriorly than adjacent haptic regions, and which are spaced apart from each other, the iris damage resist elements more deformable than adjacent haptic regions.

109. The lens of claim 108, wherein any one or more of the plurality of iris damage resist element includes any one or more features of any of an iris interface rotational resist elements herein.

110. The lens of claim 108, wherein the plurality of iris damage resist elements, when placed in an eye, each have a greater volume of aqueous than adjacent haptic regions due to having relatively fewer cross-link bonds.

111. A lens comprising, an optic and a haptic, the haptic sized and configured to interface with a sulcus of an eye, the haptic comprising a plurality of anterior surface elements that, when the lens is placed in an eye, are chemically adapted to swell more and extend further anteriorly than adjacent haptic regions.

112. The lens of claim 111, wherein the plurality of anterior surface elements are sized and positioned to be iris interface rotational resist elements.

113. The lens of claim 111, wherein the plurality of anterior surface elements are sized and positioned to be iris damage resist elements.

114. A lens, comprising an optic body and a haptic sized and configured to interface with a sulcus of an eye,the haptic including a plurality of footplates that, prior to being implanted in an eye, are chemically adapted to swell more than adjacent haptic regions when placed in the eye.

115. A lens comprising, an optic and a haptic, the haptic sized and configured to interface with a sulcus of an eye, the haptic comprising a plurality of anterior surface elements that extend further anteriorly than adjacent haptic regions.

116. The lens of claim 115, wherein each of the plurality of anterior surface elements extend further anteriorly from 5-150 microns that adjacent haptic regions.

117. The lens of claim 115, wherein each of the plurality of anterior surface elements has an elongate configuration.

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