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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 OptiBlue IOL, TECNIS Symfomy Toric II OptiBlue IOLs
Generic NameExtended depth of focus intraocular lens
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS112
Date Received02/28/2020
Decision Date05/28/2020
Product Codes MJP POE 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an addition to the TECNIS Symfony family of Extended Range of Vision one-piece IOLs manufactured from OptiBlue lens material.
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