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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 POSTERIOR CHAMBER INTRAOCULAR LENS (IOL), MODEL AR40XEM
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS007
Date Received09/30/2005
Decision Date01/04/2007
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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