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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
Generic NameLens, multifocal intraocular
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP080010
Supplement NumberS027
Date Received12/23/2024
Decision Date09/10/2025
Product Code MFK 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a new sterilization manufacturing site located at COSMED Group of Dominican Republic, Zona Franca Las Americas Km. 22 Autopista Las Americas, Santo Domingo Este Calle 15Esq. Calle 10, Santo Domingo, Santo Domingo, Dominican Republic
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