Patent ID: 12226309

DETAILED DESCRIPTION

Some aspects of this disclosure describe storage devices for an intraocular lens. Some aspects of the disclosure describe devices and assemblies for loading an intraocular lens into a delivery device or delivery lumen. In some embodiments the devices and assemblies can be used for both storage and loading.

FIGS.1-13illustrate an exemplary embodiment of an IOL loading device, including a sequence of loading an exemplary intraocular lens into a delivery device. WhileFIGS.1-13are descried in the context of intraocular lens loading, the devices and assemblies inFIGS.1-13could also be used to store the intraocular lens. “Storage” as used herein includes any time the intraocular lens is kept in the device, and includes any sterilization procedures, shipping, and/or storage.

The loading devices herein are adapted to splay at least one haptic of the intraocular lens. The embodiment shown inFIGS.1-13illustrates a device adapted to splay two haptics of an intraocular lens, and is adapted to splay the two haptics sequentially. The term “splay” (or derivatives of “splay”) as used herein refers to the act of re-orienting at least a portion of a haptic relative to an optic portion of an intraocular lens, such as from a substantial at-rest orientation in which the haptic has a generally curvilinear configuration to an orientation in which the haptic extends away from the optic. In the splayed orientation, at least a portion of the haptic does not follow the periphery of the optic portion, and extends away from the optic portion. In the splayed orientation a free end of the haptic is disposed further from the periphery of the optic than when the haptic is at an at-rest orientation relative to the optic. In the splayed orientation, at least a portion of the haptic has a more linear configuration than when the haptic is in the at-rest configuration.

The device(s) inFIGS.1-13are adapted to be used to load an IOL, such as the exemplary accommodating intraocular lens shown, into a delivery device or delivery lumen, from which the IOL is delivered into a patient's eye (such as into a capsular bag after the native capsule has been removed). A “delivery device” or “delivery lumen” as used herein may be referred to as a cartridge, and generally refers to a device or lumen that houses at least a portion of the intraocular lens for any period of time before the intraocular lens is implanted into the eye.

As an example, the loading devices and methods herein can be used to load an IOL into the cartridges described in U.S. application Ser. No. 13/835,876, filed Mar. 15, 2013, the disclosure of which is incorporated by reference herein. They can also be used to load an IOL into any suitable type of delivery device or delivery lumen.

The IOLs that can be loaded and splayed using devices and methods herein can be any type of IOL, such as accommodating, monofocal, and multifocal IOLs.FIGS.1-13illustrate the exemplary splaying of first and second haptics and the loading of a fluid-filled and fluid-driven accommodating IOL, exemplary details of which are described in U.S. application. Ser. No. 13/672,608, filed Nov. 8, 2012, while exemplary methods of delivering the IOL from the delivery device and into the eye are described in U.S. application Ser. No. 13/835,876, filed Mar. 15, 2013.

Procedures for loading and/or splaying of haptics that use many individual tools or components, and involve manually displacing an IOL from an IOL carrier or other storage device into a delivery device (e.g., cartridge) can be cumbersome and can risk damaging the lens and delivery performance. Preferable options include an assembly that allows the user to quickly, reliably, and safely introduce an IOL into a delivery device (e.g., a cartridge) without manual manipulation or at least without risk of IOL damage.

FIGS.1-13illustrate an exemplary splaying and loading lens carrier assembly that allows for safe transport of an accommodating IOL from manufacturing, through sterilization, storage, and into the operating environment. It does this with the lens in a substantially unstressed state to not alter power or shape of the lens through sterilization or storage. When ready for lens delivery, the loading IOL carrier can be mounted to a delivery device (e.g., a cartridge), which places the lens in a preferred state ready to deliver. The carriers herein are adapted to mate with cartridge and tray assemblies described in U.S. application Ser. No. 13/835,876, filed Mar. 15, 2013, such that the IOL can be loaded into those cartridges, but the disclosure is not so limited. The carrier assemblies herein can be used to load IOLs into other types of delivery devices.

As shown in the top view inFIG.1, exemplary carrier10includes base12, which acts as a tray to interface with other loading IOL carrier components as well as delivery system components (e.g., a cartridge). Base12also includes an IOL receiving region formed therein, and also acts as a guide for the IOL through the splay and loading process. The carrier assembly also includes a splay member20. The splay member is adapted to move distally and proximally within a channel or guide in base12and functions to splay leading haptic4in a direction distal to optic2of IOL3. The carrier assembly also includes loading member guide22, which houses a loading member that moves distally to engage with and advance IOL3into cartridge30(or other delivery device or delivery lumen) and placing it at a predefined position in the cartridge to be ready for further assembly of a delivery device, such as the plungers described in U.S. application Ser. No. 13/835,876, filed Mar. 15, 2013. The carrier assembly also includes a carrier cover, or lid, not shown inFIGS.1-13for clarity. The cover retains the IOL, splay member, and loading member in the assembly. It also allows for viscoelastic lubricant to be introduced into the system without disrupting the lens orientation. It also allows for visualization of the loading procedure.

FIG.1illustrates IOL3within an IOL receiving region in base12. Leading haptic4is disposed distally to optic2, and trailing haptic6is generally proximal to optic2. Splay member20is disposed within channel15in base12. Splay member20has an extension on one side of the member20that, when the splay member20in advanced in channel15, is adjacent a side wall of channel15. InFIG.1the extension is shown on the bottom of splay member20. The IOL is positioned within the receiving region, and the extension is disposed within base12, such that the extension is positioned to engage with the free end of leading haptic4and initiate the splaying process as splaying member20is advanced distally.

FIG.2illustrates an exploded view with cartridge30separate from carrier base12, but illustrating the end to which cartridge30is adapted to be secured to carrier base12.FIG.3shows cartridge30secured to base12.

FIGS.1-7illustrate an exemplary method of splaying a leading haptic of the IOL within the carrier base. Prior to use, the loading IOL carrier can be sterilized and shipped with the IOL disposed therein (as shown inFIG.1). Optionally the cartridge can be attached before sterilization, or the cartridge can be attached at the time of loading. Viscoelastic is introduced to the carrier through a port in the side of the loading IOL carrier that has a communicating port adjacent to lens, an example of which is shown inFIG.15. Addition of viscoelastic lubricates the IOL, carrier, and cartridge components to allow for orientation and movement of the lens without sticking.

FIG.1illustrates the IOL within the carrier base such that the haptics are in an at-rest configuration and orientation, and are substantially unstressed. In the at-rest orientation, the haptics are both generally curvilinear, and extending around the periphery of optic2. Trailing haptic6is oriented generally towards trailing haptic guide14, which extends radially outward from channel15. Both haptics closely follow the curvature of the optic portion, unlike some wire haptics, which extend further away from the optic portion and do not closely follow the curvature of the optic periphery.FIG.3illustrates the carrier mounted to cartridge30. When the carrier is mounted to the cartridge, as shown inFIG.3, the carrier channel15is in communication with a delivery lumen within the cartridge that is adapted to receive the IOL.

As can be seen inFIG.1, splay member20includes an elongate distal portion extending from the proximal portion and is aligned with one side of the channel so that the distal end is positioned (and adapted) to engage and push the leading haptic distally when the splay slide is advanced. The IOL is oriented rotationally inFIG.1such that the elongate portion is adapted to push on the free end of the haptic (i.e., not the end of the haptic that is directly attached to optic2). The free end is facing proximally and is accessible in the proximal direction.

FIGS.4-7are top views of base12illustrating an exemplary sequence of splaying a leading haptic of an IOL. An operator actuates splay member20to advance it distally, causing splay member20to engage with the free end of leading haptic4, as shown inFIG.5. As splay member20continues to be advanced distally, the extending portion of splay member20pushes the free end of leading haptic4away from the periphery of optic2, changing the configuration of the haptic and the haptic's orientation relative to optic2. Surgeon features in the haptic that allow for fluid (e.g., viscoelastic fluid) to be advanced or aspirated during the procedure act as a natural hinge, and leading haptic4will naturally bend at that location. The surgeon feature is described in more detail in the applications reference herein, but in general the surgeon feature is a region of decreased thickness relative to adjacent portions of the haptic that creates an opening between the optic and the haptic radially inner surface. As splay member20continues to be distally advanced, the distal end of leading haptic4continues to splay, as shown inFIG.6, starting to extend generally in the distal direction. Continued splay member20advanced continues until finger24engages pocket13in the base, and further distal movement of splay member20is prevented. Leading haptic4is splayed inFIG.7, with the free end of the haptic extending in the distal direction, and the haptic reconfigured to a splayed configuration. The trailing haptic can undergo a relatively minimal amount of deformation as the leading haptic is splayed, but is not considered to be splayed as that term is used herein. InFIG.7the trailing haptic is not yet splayed. In this embodiment the leading haptic is “actively” splayed into that an actuatable member makes direct contact with the free end of the haptic.

After the leading haptic is splayed, the IOL is then loaded into the cartridge, during which the trailing haptic is also splayed. In this embodiment the trailing haptic is passively splayed in that it is splayed as a result of a force being applied to a non-free end of the trailing haptic. The carrier base need not be moved relative to the cartridge at this point. Splay member20is not advanced any further to load the IOL into the cartridge, in this embodiment due to the stop11in the base.

FIGS.8-13illustrate an exemplary loading process that loads the IOL into the cartridge after the leading haptic has been splayed. During the loading the trailing haptic is passively splayed. A loading member40, which is optionally mechanically coupled to the splay member, is advanced distally within a channel or guide in the splay member, as shown inFIG.8. Loading member40has an elongate distal portion sized and configured for advancement within and relative to the splay member channel. The distal end of loading member40is adapted to push the IOL into the cartridge (i.e., load the IOL into the cartridge). To load the IOL, the operator distally advances loading member40, moving the IOL forward within carrier, as shown inFIGS.9and10. During the loading process trailing haptic6is deformed against the channel wall as the IOL is advanced further down the carrier channel. InFIG.10trailing haptic6is significantly splayed proximally relative optic, and bends at the surgeon feature as described above in the context of the leading haptic. The free end portions of the haptics extend away from the optic portion, while the attachment portions of the haptics do not extend away from the optic portion as much. In these embodiments the free end portions are considered the portions distal to the bend locations of the haptics. As the IOL is about to be loaded into the cartridge, the leading haptic is distally splayed and the trailing haptic is proximally splayed. With the IOL shown, free end portions of each haptic are reconfigured. Loading member40continues to be advanced until the IOL is advanced into the cartridge delivery lumen, as shown inFIG.13. As the IOL is loaded, the optic undergoes deformation due to a tapered surface of the cartridge. The haptics undergo additional reorientation relative to the optic as the IOL is advanced into the cartridge. Loading member40is sized so that the IOL is advanced to a predetermined position within the cartridge, to ensure it is advanced far enough but not out of the cartridge. A very small portion of the IOL could extend from the distal port of the cartridge. The operator then retracts the loading member within the carrier. The operator then removes the carrier from the cartridge to allow the positioning of other delivery devices, such as the delivery devices described in U.S. application. Ser. No. 13/835,876, filed Mar. 15, 2013. Optionally, an additional delivery member could be advanced through the carrier to deliver the IOL out of the cartridge.

FIG.14illustrates an additional embodiment of a carrier in which loading member40is disposed to the side of splay member20rather than axially moveable within it. Cartridge30is shown secured to the distal portion of the carrier base.

Embodiments below show a protective cartridge bay, or cartridge receiving area, included in the loading carrier base to allow the cartridge to be in the shipped assembly. The viscoelastic port (seeFIG.15) can be designed to mate to standard syringes and has a pathway that leads to proximity of the lens. The splay member and loading member can also be coupled to allow the operator to continue one motion to allow for splaying and loading of the IOL in one generally continuous act.

One or more components of the carrier can be, for example, machined white acetal copolymer, but can be any other suitable material. In alternative embodiments, a handheld loading tool can be used in place of the integrated loading slide, and is an example of using additional components with the carrier base and splay slide.

FIGS.16-32Cillustrate exemplary embodiments of intraocular lens carriers that are adapted to store intraocular lenses, as well as to load intraocular lenses into a delivery device or delivery lumen. This disclosure generally refers to a delivery device (e.g., a cartridge) as a device that is different than the carrier, but the delivery device and carrier can be considered the same device in alternative embodiments. In those embodiments the intraocular lens can be loaded into a delivery lumen of the carrier. The carriers can be used to load an intraocular lens in either way. In the embodiment inFIGS.16-32Cthey are separate components adapted to mate with one another. The carriers inFIGS.16-32Care adapted to carry the exemplary accommodating intraocular lens in a stable, lightly axially-compressed condition (referred to herein as a “compressed condition”). The intraocular lens can be carried in the compressed condition through, for example, sterilization, shipping, and storage. The carriers inFIGS.16-32Care also adapted for touch-free loading of intraocular lenses into a delivery device for delivery in an eye.

FIG.16is a top view of an exemplary intraocular lens carrier. Carrier300includes base310, splay member320, load member330, and lid350. Lid350is shown as transparent to allow intraocular lens340to be seen between lid350and base310.FIG.17shows an exploded view with base310, load member330, splay member320, lens340, and lid350. Base310has a channel or guide311(seeFIG.17) in the proximal portion adapted to receive the proximal portions of load member330and splay member320therein. As shown inFIG.16, splay member320and load member330include elongate portions that are positioned generally next to one another and extending in the proximal to distal direction (axially), while base310includes divider312that separates splay member320from load member330. Splay member320, load member330, and channel311are all configured to allow splay member320and load member330to be moved distally within channel as part of the splay and loading process below. Base310also includes load member lock out313that prevents load member330from being advanced distally until release323of the splay member (seeFIG.17) engages and displaces lock out313radially, thus allowing load member330to then be advanced distally. This prevents distal movement of load member330until splay member320has been advanced far enough distally to ensure that the leading haptic is sufficiently splayed. Splay member320and load member330are somewhat similar in function to the other splaying members and pushing members set forth above inFIGS.1-13. Base310also includes an intraocular lens receiving region314(seeFIG.17) that includes trailing haptic receiving area315.

Splay member320in this embodiment has a distal portion321with a general forked, or branched, configuration. As shown inFIG.17, distal portion321includes first extension322and second extension324of the branched configuration, with both extensions including first and second flat surfaces. The angle between the two branches of the branched configuration can be between about 60 degrees and about 120 degrees. If the angle is too large distal portion321may not index to the landing position after splaying. If the angle is too small distal end321may not be able to pick up the leading haptic at the beginning of the splay process. In the embodiment shown the angle is 90 degrees. In some embodiments the angle is between about 75 degrees and about 105 degrees. The branched configuration of distal portion321is configured to mate with splay member stop316(seeFIG.16) in base310. Second extension324includes two flat surfaces, the flat surfaces defining an internal angle less than 90 degrees (such as 75 degrees or less, 60 degrees or less, or 50 degrees or less, such as about 45 degrees). The tip of second extension324is configured to, when splay member320is advanced distally, fit just between the free end of the leading haptic and the optic portion of lens340. The positioning of extension324in this manner causes the leading haptic to start to splay when splay member is advanced, which is described in more detail below.

FIG.18shows a perspective view of carrier300and cartridge360before the cartridge is secured to the distal cartridge receiving area of carrier300.FIG.19shows the assembly after cartridge360is secured to the distal portion of carrier300. In use, as will be described below, the intraocular lens is loaded from its receiving region in carrier300into a delivery lumen in cartridge360.

FIG.20illustrates distal end331of load member330. Load member330includes an elongate body333, a first extension332extending distally and in an upward direction relative to a top portion of elongate body333at a hinge335. First extension332is adapted to rotate with respect to the portion of load body333proximal to extension332at hinge335. Load body333also includes second extension334extending distally and in a generally linear orientation with respect to the proximal portions of load body333.

FIG.21shows a view of bottom surface352of lid350. Lid350is positioned on top of a portion of base310, as shown in the exploded view inFIG.24. Lid350covers the portion of base310where the lens340is positioned. Lid350includes a plurality of posts353, which are adapted to fit within post guides317in base310(seeFIG.17) to help stabilize lid350with respect to base310. In this embodiment there are three posts, although more or less can be used. It may be beneficial to use three posts, which develop a simple plane, whereas more posts may increase the risk of over constraint which could lead to increased variation in lens compression. Lid350also includes sight or probe apertures354, which are described below. Lid350also includes a plurality of compression spokes355that extend downward (i.e., in the same direction as posts353) from the bottom surface352of the lid. In this embodiment there are four compression spokes355, and they have linear configurations extending radially away from the center of the lens receiving region.

Base310and lid350are adapted and configured to provide advantages when storing intraocular lens340for periods of time. Some types of accommodating intraocular lenses may be susceptible to undergoing power changes during storage due to, for example, degradation of IOL materials or forces on the lens from the packaging components. Eliminating or greatly reducing power changes during storage, or at least making them predictable, is highly desirable. For example, lens340can be a fluid-driven accommodating intraocular lens such as those incorporated by reference herein. For example, the two haptics may include fluid chambers in fluid communication with the option portion. If the haptics are compressed too greatly over time, fluid may transfer between the haptics and optics, causing power changes to the IOL. The compression spokes355of lid350provides a sufficient amount of compression to haptics to stabilize them without distorting them. The spokes also isolate interaction between the haptics and the carrier to the spokes, which prevents haptic compression coming from a larger surface such as the lid bottom surface. That is, the haptics are maintained in desired configurations so that the IOL power change is predictable during storage. The manner of controlling the degree of haptic compression in this embodiment uses an assembly method with finely controlled post height coupled with an equally controlled height of the lens compression feature, in this embodiment the spokes. The bottoming of the posts in the mating part of carrier base310controls a well-defined compression between a base surface on which the lens rests and the lens compression spoke. This compression holds the lens in a stabilized position through storage, which can include sterilization and shipping.

In this embodiment the posts are designed to sit on the plane of the base on which the haptics are disposed (in their respective pockets). This plane thus acts as a reference plane, or zero height. In some embodiments the haptics have a height of about 2.88 mm. Some haptics may have a designed height slightly greater than their actual height in the configuration in the base. In some embodiments the distance between the bottom of the spokes and the base surface on which the lens rests is between about 2.750 mm and about 2.850 mm. In some embodiments this distance is just less than the haptic height. In some embodiments the spoke height is about 0.200 mm. This distance isolates the interaction between the haptic and the carrier to the spokes alone and prevents compression coming from a larger surface.

The compression to the haptics is limited to locations on the haptic that result both in low deformation of the haptic and high holding stability.FIG.22illustrates the relative position of spokes355and haptics341and342. IOL340includes an optic portion coupled to two haptics. Each of the haptics includes a buttress portion secured to the optic, as is described in the applications incorporated by reference. Two of the spokes each engage distal portions of the haptics. The other two spokes engage buttress portions of the haptics. Two of the spokes are disposed along the same imaginary line, while the other two spokes are disposed along the same imaginary line. The spokes are arranged so that they engage the same regions of each of the two haptics. The light compression stabilizes the power and quality of the lens through radiation or other sterilization processes as well as temperature changes or vibration effects of shipping. The light compression also holds the lens in position through the initiation of the splaying and loading sequences described herein.

The carrier is also adapted for lens compression verification. In this embodiment lid350includes probe or sight holes354(three are shown) that allow for the measurement of the compression level after the lens is in place within the base and the lid has been assembled onto the base. In some embodiments this can be performed by measuring the spoke to lens base gap through the lid and sight hole with a non-contact laser measurement system.

The carrier can also be adapted to enable verifying the intraocular lens quality or power during or after storage. This may be desirable in general, or in particular because some intraocular lenses have the potential to take on a very small permanent set through sterilization or due to aging, and thus there may be a need to verify quality and power change of the intraocular lens in the stored configuration.

One method of assessing the circularity of a reflected concentric ring pattern may be used to look at lens quality before or after compression of the lens. If this is to be done after the compression of the lens (e.g., after storage), the lid can be adapted with a window that would allow for this. In fact, the lid can include a plurality of windows (and/or the base could include one or more windows) and may be needed to allow for optical verification of the power and quality of the lens after being compressed.

FIGS.23-31Dillustrate examples of the lid and/or the base including one or more visualization windows formed therein. In embodiments in which at least one of the base and lid include one or more windows, one or more plugs should generally be included to complete the viscoelastic path for preparing to load the intraocular lens as well as for sealing the lens path for loading. Plugs can be shipped attached to the finished assembly, but in some embodiments the plugs are installed in the operating room just prior to loading to reduce the risk of disturbing the known compression.

FIGS.23A and23Bshow top and bottom views, respectively, of exemplary carrier400that includes base410with a window and corresponding base plug454, and lid450with a window and corresponding lid plug452. Other components in the embodiments inFIGS.16-22are intended to be included in these embodiments even if not specifically mentioned herein. The plugs can be removed, respectively, to visualize the top or bottom of the IOL that is disposed inside the carrier. The windows are positioned within the lid and base in order to visualize the optic portion of the intraocular lens, as is shown inFIG.24with lid plug452removed. Lid450is shown as transparent to enable visualization of leading haptic441, trailing haptic442, and other components of the carrier. Optic portion443is viewed through window456.

FIGS.25A and25Bare perspective exploded top and bottom views, respectively, or lid450, window456formed therein, and plug452. Plug452includes a slot portion that is aligned with the slot in the bottom surface of the lid, as is described herein.FIGS.26A and26Bshow assembly views ofFIGS.32A and32B.

FIGS.27A-30illustrate an exemplary embodiment of base410that includes a window on the bottom to allow visualization of the intraocular lens optic. Base410and base plug480are configured to mate and to be secured together so that window412can be plugged with plug480.FIG.27Ashows a top perspective exploded view of base410and plug480.FIG.27Bshows a close-up bottom perspective exploded view of base410, including window412, and plug480.FIG.28is a perspective view of plug480showing fluid communication between fluid port481of plug480, internal fluid channel483, and outlet fluid port482. The shape of the plug is shaped to mate with the base. Plug480is, in this embodiment, secured to base410with seven deformable locks414, which are part of base410. Only three of the locks414are labeled inFIG.27B.FIG.30show a bottom view with plug in place to plug up the window, showing the locks414that hold plug in place. The plug can be removed by pulling on the fluid port481outer surface, in a downward direction.FIG.29shows the plug480and base410assembled, with outlet fluid port482in fluid communication with the inside of base410. Plug480includes an element484(seeFIG.28) adapted to fit within window412. In this embodiment they are circular, but could be a different shape. In this embodiment the base plug includes a fluid port, which will be described below in the context of the methods of use.

FIGS.31A-31Bshow top and bottom assembled views of the lids, bases, and plugs in the embodiments inFIGS.25A-30.FIG.31Ais a top view, whileFIG.31Cis a top close-up view of plug452.FIG.31Bis a bottom view, whileFIG.31Dis a close-up of that view.

The disclosure also includes exemplary methods of loading an exemplary intraocular lens from any of the carriers herein into an exemplary cartridge, wherein the intraocular lens can be subsequently be delivered from the cartridge into an eye. The methods will be described generally without reference to specific parts of the devices herein, although examples will be given in the context of certain embodiments. Not all steps need necessarily be performed, and the order may vary. Before the IOL is loaded into the cartridge, however, the IOL may be stored in the carrier for any length of time. To prepare the IOL for storage, the intraocular lens is positioned in the IOL receiving region in the carrier base, such as IOL receiving region314shown inFIG.17. The lid is then placed on top of the base, while positioning the posts in the post guides.

When the IOL is ready to be loaded in the cartridge (or other delivery device or delivery lumen), a cartridge can be secured to the carrier base, such as is shown inFIGS.18and19. InFIGS.18and19carrier300includes mounting tabs372and374that are asymmetric. Tab372is longer than tab374, both of which are adapted to engage with asymmetric apertures382and384in cartridge360. This can help position the cartridge right side up, so that the bevel at the distal end of the cartridge is facing down when the IOL is delivered from the cartridge. The asymmetric tabs also protect the user from mounting the cartridge upside down, which would result in an inverted lens delivery.

After the cartridge is secured to the carrier base, a viscoelastic substance is then introduced through a side luer port of the carrier base to fill the lens chamber in the carrier base, which lubricates the lens and the loading path. An exemplary side port is port319shown inFIG.16. Alternatively, tab480shown inFIG.27A-30can be the side port. A mark399(seeFIG.21) defined on the lid or base shows the correct volume of viscoelastic for use. Mark399as shown inFIGS.21and22is about a 30 degree arc.

As can be seen inFIG.17, side port319is in fluid communication with an exit fluid port on the bottom of the base in the IOL receiving region, similar in configuration to port482in plug480. The port conveys viscoelastic from a syringe or other viscoelastic delivery aid to the area around the IOL prior to the splaying and loading steps. The location of the fluid exit port that is nearest the lens should be positioned so that flow of the viscoelastic does not dislocate the IOL from its position prior to splaying and loading. In the embodiment inFIG.17, the location of the exit port is at the center of the optic portion receiving area, however is could be moved to other locations, such as closer to the leading haptic. The size of this port can control the user's ability to create flow. In some embodiments the orifice diameter is about 0.010 in.

It is of note that the IOL is maintained in a position in which the leading haptic buttress shoulder, where the haptic is coupled to the optic portion, is in close proximity to the buttress traction pad on the base, such as buttress traction pad318shown inFIG.16. This is generally important for stability of the IOL's position as the leading haptic is splayed.

The method of loading also includes splaying the leading haptic.FIGS.32A-32Cillustrate a sequence of loading the IOL fromFIG.16(only a portion of the carrier is shown for clarity). InFIG.32Athe IOL is positioned in the carrier base just as is shown inFIG.16. The free end of the leading haptic is proximally facing and is accessible in the proximal direction for direct contact and actuation. To initiate the leading haptic splaying, splaying member320is advanced distally within the carrier. Extension324on splaying member320is configured to fit between leading haptic341and optic portion343as splaying member320continues to be advanced distally. As splaying member320continues to be advanced distally, splaying member320engages leading haptic341, bending leading haptic341away from optic portion343and towards the cartridge. Region345of leading haptic341is a thinner region of haptic341and is described in more detailed in the applications incorporated by reference herein. Region345acts similar to a living hinge, so that as splaying member320is advanced, haptic341will reliably bend at the hinge (seeFIG.32B). Splay member320is advanced until the distal end321engages splay member stop316, as shown inFIG.32B. InFIG.32Bleading haptic341has been splayed distally, and has been reoriented from the at-rest orientation (relative to the optic) inFIG.32Ato an orientation that extends away from the optic, and generally faces distally towards the cartridge delivery lumen.

As splaying member320is advanced and as it engages stop316, release323will push lock-out313radially, allowing push member330to be advanced distally to load the IOL.

Push member330is then advanced distally within the carrier base as shown inFIG.32C. Extension332, which in an at-rest state extends slightly upward from body333(seeFIG.20) rides in slot356in lid350(seeFIG.17). Extension332is pressed over the top of the optic portion343by a descending ramp in the lid slot356, as can be seen inFIG.17. Positioning extension332over the optic portion adds axial stability to the optic for the force applied to the trailing buttress by the second extension334of the push member (seeFIG.20). Second extension334introduces a force to the trailing buttress, as can be seen inFIG.32C, while stabilizing it so it does not shift under second extension334as it moves forward. Any trailing haptic material that slides under the second extension334into space337(seeFIG.20) during movement has ample clearance under second extension334and is protected from being pinched. Positioning the first extension332over the optic helps create the fold of the optic along the line of the first extension332as the IOL enters the tapering distal section of the carrier, as shown inFIG.32C. Pusher member330continues to be advanced until the trailing haptic is splayed as well extending proximally away from the optic portion. Pusher member330continues to be advanced until the IOL enters into the cartridge, in the same general configuration as shown inFIG.13. Method steps described above with respect toFIGS.1-13can also occur during the splaying and loading methods described with respect toFIGS.32A-32C.