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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 IOL with TECNIS Simplicity Delivery System, Models DXW150-375;
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS178
Date Received09/26/2025
Decision Date10/24/2025
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  
the implementation of a revised sampling process for torque testing of the pre-loaded Simplicity and SmartLoad delivery systems at the JJSV-AMO manufacturing facility in Groningen, The Netherlands
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