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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 Next-Generation Presbyopia-Correcting IOL
Generic NameLens, multifocal intraocular
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS156
Date Received12/02/2022
Decision Date05/23/2023
Product Code MFK 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for TECNIS Next-Generation Presbyopia-Correcting (PC) Intraocular lens (IOL) with TECNIS SimplicityTM Delivery System, Model DRN00V which is a design modification of TECNIS Synergy IOL, Model DFR00V.
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