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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® Multifocal 3-Piece IOL, Model ZMA00
Generic NameLens, multifocal intraocular
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP080010
Supplement NumberS025
Date Received05/29/2024
Decision Date06/17/2024
Product Code MFK 
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  
add a new haptic-loop inspection vision system to the production process of the SENSAR® Soft Acrylic Posterior Chamber IOL, Models AR40e, AR40E, and AR40M, TECNIS® Foldable Acrylic IOL with OptiEdge, ZA9003, and TECNIS® Multifocal 3-PC, Model ZMA00 IOLs at the JJSV Añasco, Puerto Rico manufacturing site
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