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The Sovereign™ Cataract Extraction System is a phacofragmentation system for use with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract. The Sovereign™ Cataract Extraction System is designed to provide the surgical capabilities desired by the Anterior Segment/Cataract Surgeon for use in the cataract extraction.

The Sovereign™ Cataract Extraction System is a phaccemulsification system which is used by ophthalmic surgeons during cataract surgery. Accessories, which are connected to the consoles, aid the surgeon in breaking up and removing the cataract from the patient's eye. The Sovereign™ Cataract Extraction System is a modification of a previous device and is substantially equivalent to the predicate devices listed above.

The Eye Irrigator, Ocular Irrigating System, is indicated for use as an eyeirrigating device. It is designed especially for post-traumatic injury, chemical exposure and burns, permitting irrigation of the eye and under the upper eyelid, with sterile saline.

The Eye-Deal Eye Inigator, an ocular irrigator, consists of a plastic irrigation tube that works like a shower-head to irrigate continuously from under the upper eye-lid. The device is held in place with the lower speculum wire resting within the lower lid. The frame of the irrigator can be applied using adhesive tape provided, to the cheek of the patient, to stabilize the irrigator during the procedure. The device is designed to provide approximately 20 minutes of irigation using a standard saline bag.

For infusion of fluid and air during vitrectomy.

During a vitrectorny, it is necessary to irrigate balanced salt solution (BSS) into the eye to replace the natural vitreous. If a retinal hole is present, the surgeon must then replace the balanced salt solution (BSS) with air to prevent the fluid from remaining under the retina. One of the problems associated with fluid/air exchange is development of cataracts. The Moistair™ Tubing Set humidifies the dry air prior to introduction into the eye. In order to humidify the air, 1 cc of balanced salt solution (BSS) is injected into the injection port on the humidifying filter prior to use.

For intermittent or continous irrigation, flushing, and cleansing of eyes

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