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Indications and Important Safety Information
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TECNIS IOL Technology


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THE NEW TECNIS® 1-PIECE IOL PROVIDES THE UNMATCHED BENEFITS OF TECNIS® TECHNOLOGY IN A NEXT-GENERATION ONE-PIECE DESIGN.

Y. Ralph Chu, MD

Y. Ralph Chu, MD
Edina, Minnesota

TECNIS® 1-Piece IOL’s innovative ProTEC 360° edge design, and Tri-Fix stability, combine with the proven TECNIS® optic and material to deliver the next generation in one-piece lenses.”

 

Donald R. Nixon, MD, FRCSC

Donald R. Nixon, MD, FRCSC
Ontario, Canada

“After 20 years in practice, my expectations for IOL performance are very high. The TECNIS® 1-Piece IOL has surpassed these expectations, especially for visual outcomes and optic clarity. In addition, this new generation one-piece design has responded to the issues associated with existing one-piece IOLs.”

 

Mark Packer, MD

Mark Packer, MD
Eugene, Oregon

“The TECNIS® intraocular lens is the best choice for the majority of the population in terms of correction of spherical aberration.”

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.

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