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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 CL FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL Z9002)
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP880081
Supplement NumberS032
Date Received05/30/2006
Decision Date07/20/2006
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in haptic material, addition of the optiedge and of a modified prolate anterior optic surface to the si20nb lens and labeling claims for reduced postoperative spherical aberrations and improved night-driving simulator performance. The device, as modified, will be marketed under the trade name tecnis cl foldable silicone posterior chamber intraocular lens (model z9002) and is indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular extraction or phacoelmulsifica-tion. These devices are intended to be placed in the capsular bag.
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