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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTECNIS FOLDABLE ACRYLIC INTRAOCULAR LENS MODEL ZA9003
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP990080
Supplement NumberS006
Date Received03/14/2005
Decision Date04/13/2005
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE TECNIS FOLDABLE ACRYLIC INTRAOCULAR LENS MODEL ZA9003 WITH CLAIMS REGARDING REDUCTION IN POSTOPERATIVE SPHERICAL ABERRATIONS COMPARED TO LENSES WITH SPHERICAL OPTICS AND IMPROVED NIGHT DRIVING SIMULATOR PERFORMANCE.
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