CENTURION® Vision System

CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

As part of a properly maintained surgical environment, it is recommended that a backup IOL Injector be made available in the event the AutoSert® IOL Injector Handpiece does not perform as expected.

Indication: The CENTURION® Vision system is indicated for emulsification, separation, irrigation, and aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intraocular lens injection. The AutoSert® IOL Injector Handpiece is intended to deliver qualified AcrySof® intraocular lenses into the eye following cataract removal.

The AutoSert® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert® IOL Injector Handpiece is indicated for use with the AcrySof® lenses SN6OWF, SN6AD1, 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.

Warnings: Appropriate use of CENTURION® Vision System parameters and accessories is important for successful procedures. Use of low vacuum limits, low flow rates, low bottle heights, high power settings, extended power usage, power usage during occlusion conditions (beeping tones), failure to sufficiently aspirate viscoelastic prior to using power, excessively tight incisions, and combinations of the above actions may result in significant temperature increases at incision site and inside the eye, and lead to severe thermal eye tissue damage.

Good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye. Ensure that tubings are not occluded or pinched during any phase of operation.

The consumables used in conjunction with ALCON® instrument products constitute a complete surgical system. Use of consumables and handpieces other than those manufactured by Alcon may affect system performance and create potential hazards.

AEs/Complications: Inadvertent actuation of Prime or Tune while a handpiece is in the eye can create a hazardous condition that may result in patient injury. During any ultrasonic procedure, metal particles may result from inadvertent touching of the ultrasonic tip with a second instrument. Another potential source of metal particles resulting from any ultrasonic handpiece may be the result of ultrasonic energy causing micro abrasion of the ultrasonic tip.

ATTENTION: Refer to the Directions for Use and Operator’s Manual for a complete listing of indications, warnings, cautions and notes.

INFINITI® Vision System

Caution: Federal law restricts this device to sale by, or on the order of, a physician.

Indication: 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.

- 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, 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.

Warnings: Appropriate use of INFINITI® Vision System parameters and accessories is important for successful procedures. Use of low vacuum limits, low flow rates, low bottle heights, high power settings, extended power usage, power usage during occlusion conditions (beeping tones), failure to sufficiently aspirate viscoelastic prior to using power, excessively tight incisions, and combinations of the above actions may result in significant temperature increases at incision site and inside the eye, and lead to severe thermal eye tissue damage.

Adjusting aspiration rates or vacuum limits above the preset values, or lowering the IV pole below the preset values, may cause chamber shallowing or collapse which may result in patient injury. When filling handpiece test chamber, if stream of fluid is weak or absent, good fluidics response will be jeopardized. Good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye.

Ensure that tubings are not occluded or pinched during any phase of operation.

AEs/Complications: Use of the INFINITI® Vision System handpieces in the absence of irrigation flow and/ or in the presence of reduced or lost aspiration flow can cause excessive heating and potential thermal injury to adjacent eye tissues.

ATTENTION: Refer to the directions for use for a complete listing of indications, warnings and precautions.

DisCoVisc® OVD Brief Statement

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Indications: DisCoVisc® Ophthalmic Viscosurgical Device is indicated for use during surgery in the anterior segment of the eye. It is designed to create and maintain space, to protect the corneal endothelium and other intraocular tissues and to manipulate tissues during surgery. It may also be used to coat intraocular lenses and instruments during cataract extraction and IOL insertion.

Warnings: Failure to follow assembly instructions or use of an alternate cannula may result in cannula detachment and potential patient injury.

Precautions: Precautions are limited to those normally associated with the surgical procedure being performed. Although sodium hyaluronate and sodium chondroitin sulfate are highly purified biological polymers, the physician should be aware of the potential allergic risks inherent in the use of any biological material.

Adverse Reactions: DisCoVisc® Ophthalmic Viscosurgical Device was very well tolerated in nonclinical and clinical studies. A transient rise in intraocular pressure in the early postoperative period may be expected due to the presence of sodium hyaluronate, which has been shown to affect such a rise. It is therefore recommended that DisCoVisc® OVD be removed from the anterior chamber by thorough irrigation and/or aspiration at the end of surgery to minimize postoperative IOP increases.

ATTENTION: Reference the Directions for Use for a complete listing of warnings and precautions.