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2011.05.18-CT3451

Indications and Important Safety Information

TECNIS® IOLs

Caution

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

Indications

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.

Instructions For Use (Click below for the full version)

TECNIS® 1-Piece IOL(PDF)
TECNIS® Foldable Acrylic IOLs with OptiEdge Design(PDF)
TECNIS® CL Foldable Silicone IOL with OptiEdge Design (PDF)
UNFOLDER® Platinum 1 Series Handpiece (PDF)
UNFOLDER® Platinum 1 Series Cartridge (PDF)
One Series Ultra Cartridge (PDF)
UNFOLDER® Emerald Inserter (PDF)

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