IMPORTANT SAFETY INFORMATION

Indication

The INFINITI^® Vision System with OZil^® IP is indicated for emulsification and removal of cataracts, vitreous aspiration and cutting associated with anterior vitrectomy, and bipolar coagulation.

Caution:

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

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.

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

Use of the NeoSoniX^®, OZil^® torsional, U/S, or AquaLase^® 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:

Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions.