Important Safety Information – TECNIS® 1-Piece IOL
Federal law restricts this device to sale by or on the order of a physician.
TECNIS® 1-piece lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag.
Warnings: Physicians considering lens implantation under any of the conditions described in the Directions for Use labeling should weigh the potential risk/benefit ratio prior to implanting a lens.
Precautions: Do not resterilize or autoclave. Use only sterile irrigating solutions such as balanced salt solution or sterile normal saline. Do not store in direct sunlight or over 45°C.
Adverse Events: The most frequently reported adverse event that occurred during the clinical trial of the 1-Piece lens was macular edema, which occurred at a rate of 3.3%. Other reported reactions occurring in less than 1% of patients were secondary surgical intervention (pars plana vitrectomy with membrane peel) and lens exchange (due to torn lens haptic).
Attention: Reference the Directions for Use for a complete listing of indications, warnings, and precautions.