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The INFINITI® Vision System is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. The INTREPID® AutoSert® IOL Injector Handpiece is intended to deliver qualified AcrySof® intraocular lenses into the eye following cataract removal. The following system modalities additionally support the described indications: - Ultrasound with UltraChopper Tip achieves the functionality of cataract separation. - AquaLase achieves the functionality for removal of residual cortical material and lens epithelial cells. - The INTREPID® AutoSert® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The INTREPID® AutoSert® IOL Injector Handpiece is indicated for use with AcrySof® lenses SN60WF, SN6AD1, and SN6AT3 through SN6AT9, as well as approved AcrySof® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

The INFINITI® Vision System is unchanged from the INFINITI® Vision System (Evergreen II - K112425) and maintains the modular design and incorporated features that include: Power Watch feature, UltraChopper tip, the AquaLase Capsule Wash Tip, the INTREPID® AutoSert™ IOL Injector Handpiece, and the system's associated software.

The Infinit® Vision System is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. The AutoSert™ IOL Injector Handpiece is intended to deliver qualified AcrySof® intraocular lenses into the eye following cataract removal. The following system modalities additionally support the described indications: - Ultrasound with UltraChopper Tip achieves the functionality of cataract separation. - AquaLase achieves the functionality for removal of residual cortical material and lens epithelial cells - The AutoSert ™ IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert™ is indicated for use with ACRYSOF lenses SN60WF and SN6AD1, as well as approved AcrySof lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

The Infinit® Vision System is an enhanced version of the Infinit® Vision System with OZil® IP (K082845) that is modular in design and incorporates the Power Watch feature, along with the Alcon UltraChopper Tip, the AquaLase Capsule Wash Tip, the AutoSert™ IOL Injector, and its associated software.

This MONARCH® III P Cartridge IOL insertion device is indicated to fold/hold and insert Alcon IOLs that have the use of this inserter in their approved labeling.

The Monarch® III IOL Delivery System (P Cartridge), hereafter referred to as the Monarch® III P Cartridge, is a modification to the previously cleared Alcon Monarch® III IOL Delivery System (D Cartridge) consisting of a disposable polypropylene cartridge and reusable titanium handpiece. The Monarch® III P Cartridge features nozzle tip sizing like the currently marketed Monarch® III D Cartridge and is intended to fold and deliver Alcon AcrySof® intraocular lenses into the anterior chamber of the eye. It is designed to work with the currently marketed Monarch® III handpiece.

The Constellation® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.

The Constellation® Vision System is a combined anterior and posterior procedure ophthalmic system that is modular in design and serves as an enhanced version of the Alcon Vision System. The Constellation® Vision System is designed for use in anterior and posterior procedures that require infusion, vitreous cutting, and illumination as well as irrigation, lens emulsification and fragmentation, cautery and diathermy. The system was developed with a dual purpose: to make it simple to operate, and to allow the surgeon control and flexibility.

The AquaLase® Capsule Wash Tip is indicated to assist in the removal of residual cortical material and lens epithelial cells.

The AquaLase® Capsule Wash Tip is a sterile, single-use product. It is an accessory to the AquaLase® Handpiece (K980292), which produces the heated intraocular irrigating solution (Balanced Salt Solution or equivalent fluid) that washes the capsular surface. The AquaLase® Capsule Wash Tip and the AquaLase® Handpiece are accessories to the INFINITI® Vision System (K021566). The AquaLase® Capsule Wash Tip utilizes existing packaging configurations and has the same shelf life as existing AquaLase® tips. To use the AquaLase® Capsule Wash Tip as intended, no modification to the existing INFINITI® System is required.

The MONARCH® III IOL Delivery System is used for implantation of ALCON® qualified ACRYSOF® intraocular lenses into the eye following cataract removal.

The Monarch© III IOL Delivery System is a modification to the previously cleared Alcon Monarch(r) II IOL Delivery System (K003768) consisting of a disposable cartridge and reusable handpiece. The Monarch II cartridges are designated as A, B, and C, and feature various nozzle tip sizes that correspond to the various AcrySof® IOL models. As with the cleared cartridges, the Monarch© III IOL Delivery System presented in this submission utilizes a one-piece disposable cartridge (designated as D) with progressive folding in combination with a reusable handpiece (H4). This new cartridge possesses the same basic inner lumen design and lens guiding mechanisms as the existing Monarch*) II A, B, and C cartridges, but differs in nozzle tip sizing.