Important Safety Information – Tecnis® IOLs (For Physicians)
Federal law restricts this device to sale by or on the order of a physician.
Tecnis 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: Adverse events occurred at rates between 1.6% and 3.3% during the clinical trials for Tecnis® IOLs or their "parent" IOLs. These events included macular edema, endophthalmitis, anterior lens tissue ongrowth, lens dislocation, hypopyon, corneal edema, iritis, hyphema, secondary glaucoma, and secondary surgical intervention.
Attention: Reference the Directions for Use for a complete listing of indications, warnings, and precautions.