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The D.O.R.C. Disposable Cryo Probe is intended for use in combination with the Cryostar Cryosurgical System to perform ophthalmic surgery of the posterior segments including cryopexy for retinal detachment, glaucoma, cataract extraction, trichiasis, and retionopathy of prematurity.

The D.O.R.C. Disposable Cryo Probe is a single-use, handheld medical device intended for use in combination with the Cryostar Cryosurgical System to perform ophthalmic surgery. When the foot pedal of the CryoStar Console is pressed, high pressure gas (CO2 or N2O) is supplied via a small aperture to target tissue.

The EVA Ophthalmic Surgical System is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. In addition, the optional laser is indicated for the following: | Condition | Treatment | |----------------------------------------------------------------------------------|-----------------------------------| | Diabetic Retinopathy | | | • Proliferative Diabetic Retinopathy | Panretinal Photocoagulation | | • Clinically Significant Macular Edema | Focal or Grid Laser | | Retinal Tear and Detachments | Laser Retinopathy | | Lattice Degeneration | Retinal Photocoagulation | | Sub-retinal (choroidal) Neovascularization | Focal Laser | | Retinal Vascular Occlusion | | | • Neovascularization secondary to Brand or Central retinal<br>vein occlusion | Scatter Laser<br>Photocoagulation | | • Chronic macular edema secondary to Branch or Central<br>retinal vein occlusion | Focal or Grid Laser | | Glaucoma | | | • Primary Open-angle | Trabeculoplasty | | • Closed Angle | Iridotomy or Iridoplasty |

The EVA Ophthalmic Surgical System (EVA) is a combined anterior and posterior procedure ophthalmic system that is modular in design and serves as an enhanced version of the currently cleared Associate (K081877). The EVA is designed for use in anterior and posterior procedures that require infusion, vitreous cutting, aspiration, illumination, irrigation, lens emulsification and fragmentation, cautery, diathermy as well as photocoagulation.

The ASSOCIATE is intended for ophthalmic anterior and posterior segment surgery. It provides capabilities for phacoemulsification, phacofragmentation, diathermy coagulation, irrigation/aspiration, vitrectomy, illumination, air/fluid exchange and silicone oil injection & extraction.

The Associate is medical electrical equipment to be used during eye surgery. The Associate is intended for ophthalmic anterior and posterior segment surgery. It provides capabilities for phacoemulsification, phacofragmentation, diathermy coagulation, irrigation/ aspiration, vitrectorny, illumination, air/fluid exchange, silicone oil injection and extraction. The equipment has a display with touch screen for selecting and activating the functions. With the equipment a footswitch and a remote control are delivered for control by the surgeon. The equipment can be installed on a trolley and is able to control an automated infusion pole.

The Xenon BrightStar Illumination System is intended to provide intraocular illumination in vitreoretinal surgery.

The Xenon BrightStar Illumination System consists of the Illumination Unit and accessories. The Illumination Unit uses a Xenon Short Arc Lamp and utilizes two internal focusing systems to focus the light into the end of an optical fiber of two individually controlled ports. Both ports can be individually controlled by choice of an UV cut-off filter and a light intensity setting. Accessories trother system include single use and reusable fiber optic probes, fibers and micro instruments which are delivered sterile or require sterilization prior to use.