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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 Symfony Toric II OptiBlue Extended Range of Vision (ERV) IOLs
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS131
Date Received02/09/2021
Decision Date03/08/2021
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Additional image quality manufacturing process step for the TECNIS Symfony Toric II OptiBlue ERV lOLs, Models ZXW50, ZXW225, ZXW300, ZXW375 manufactured at the AMO Groningen B.V. facility.
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