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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 NameTECNIS FOLDABLE ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENS (IOL), MODEL AR40XEM
Classification Nameintraocular lens
Generic Name intraocular lens
Regulation Number886.3600
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP980040
Supplement NumberS007
Date Received09/30/2005
Decision Date01/04/2007
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - performance characteristics
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to market model ar40xem intraocular lens (iol) under the tecnis trade name and for the following labeling claims: 1) improved mesopic contrast sensitivity; 2) improved mesopic low-contrast acuity; and 3) reduced spherical aberration.
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