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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameFOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS TECNIS, WITH Z-SHARP OPTIC TECHNOLOGY
Classification Nameintraocular lens
Generic Nameposterior chamber intraocular lenses
Regulation Number886.3600
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP990080
Supplement NumberS004
Date Received04/15/2003
Decision Date03/01/2004
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to revise the package insert with claims regarding reduction in postoperative spherical aberrations compared to lenses with spherical optics and improved night driving simulator performance. The device, as modified, will be marketed under the trade name tecnis and is indicated for primary implantation for the visual correction of aphakia in adults in whom a cataractous lens has been removed by phacoemulsifi-cation. The lenses are intended to be placed in the capsular bag.
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