UNITY® VCS and CS Important Product Information

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

Indications / Intended Use:

UNITY VCS:

The UNITY VCS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e. vitreoretinal) ophthalmic surgery. In addition, with the optional laser this system is indicated for photocoagulation (i.e. vitreoretinal and macular pathologies), iridotomy and trabeculoplasty procedures.

UNITY CS:

The UNITY CS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) ophthalmic surgery.

Warnings:

Appropriate use of UNITY VCS and CS parameters and accessories is important for successful procedures. The console supports various accessories to perform various surgical procedures. Accessories include handpieces and probes, as well as tips and sleeves when necessary. Different accessories are required for different procedures and operating modes.

Test for adequate irrigation and aspiration flow, reflux, and operation of each accessoryprior to entering the eye.

The consumables used in conjunction with ALCON® instrument products constitute a complete surgical system. To avoid the risk of a patient hazard, do not mismatch consumable components or use settings not specifically adjusted for particular consumable component combinations.

AEs/Complications:

Inadvertent activation of functions that are intended for priming or tuning accessories while the accessory is in the eye can create a hazardous situation that could 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 for the accessories/consumables and User Manual for a complete listing of indications, warnings, cautions and notes.