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MIVS Important Product Information

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

Indications for Use: 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.

The ULTRAVIT® Vitrectomy Probe is indicated for vitreous cutting and aspiration, membrane cutting and aspiration, dissection of tissue and lens removal. The valved entry system is indicated for scleral incision, canulae for posterior instrument access and venting of valved cannulae. The infusion cannula is indicated for posterior segment infusion of liquid or gas.

Warnings and Precautions:

• The infusion cannula is contraindicated for use of oil infusion.
• Attach only Alcon supplied products to console and cassette luer fittings. Improper usage or assembly could result in a potentially hazardous condition for the patient. Mismatch of surgical components and use of settings not specifically adjusted for a particular combination of surgical components may affect system performance and create a patient hazard. Do not connect surgical components to the patient's intravenous connections.
• Each surgical equipment/component combination may require specific surgical setting adjustments. Ensure that appropriate system settings are used with each product combination. Prior to initial use, contact your Alcon sales representative for in-service information.
• Care should be taken when inserting sharp instruments through the valve of the Valved Trocar Cannula. Cutting instrument such as vitreous cutters should not be actuated during insertion or removal to avoid cutting the valve membrane. Use the Valved Cannula Vent to vent fluids or gases as needed during injection of viscous oils or heavy liquids.
• Visually confirm that adequate air and liquid infusion flow occurs prior to attachment of infusion cannula to the eye.
• Ensure proper placement of trocar cannulas to prevent sub-retinal infusion.
• Leaking sclerotomies may lead to post operative hypotony.
• Vitreous traction has been known to create retinal tears and retinal detachments.
• Minimize light intensity and duration of exposure to the retina to reduce the risk of retinal photic injury.

ATTENTION: Please refer to the CONSTELLATION® Vision System Operators Manual for a complete listing of indications, warnings and precautions.