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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 1-Piece IOL with TECNIS® iTEC Preloaded Delivery System Model PCB00, TECNIS Multifocal 1-PC IOL with TECNIS® iTEC
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS154
Date Received11/17/2022
Decision Date12/15/2022
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Changes to the torque testing of the preloaded IOL delivery systems of soft acrylic one-piece IOLs manufactured in Puerto Rico.
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