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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® Toric II 1-Piece IOLs, TECNIS Symfony™ Toric II Extended Range of Vision IOLs, TECNIS Eyhance™ IOL, TECNIS Eyhan
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS157
Date Received02/10/2023
Decision Date03/06/2023
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  
Modification to the endotoxin extraction method used during endotoxin testing of intraocular lenses manufactured at the AMO Groningen manufacturing site, and packaged in either the TECNIS Simplicity Delivery System or the daisywheel packaging configuration.
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