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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® 3-Piece Multifocal
Generic NameLens, multifocal intraocular
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP080010
Supplement NumberS022
Date Received06/28/2023
Decision Date09/27/2024
Product Code MFK 
Advisory Committee Ophthalmic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
software improvements made to optical metrology system used for 100 percent in-line inspection of TECNIS 3-Piece Acrylic Monofocal, TECNIS 1-Piece with TECNIS® iTec Preloaded Delivery System, SENSAR® 3-Piece Monofocal, TECNIS® CL Foldable Silicone, and 5ODEL SI-11NB UV Absorbing Silicone Posterior intraocular lenses
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