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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 Eyhance™ Toric II IOLs with SmartLOAD™ Delivery Technology (GIU150-600)
Generic NameLENS, INTRAOCULAR, TORIC OPTICS
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS182
Date Received02/27/2026
Decision Date05/19/2026
Product Code MJP 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for TECNIS Eyhance™ Toric II one-piece IOLs in the SmartLOAD™ Delivery Technology packaging configuration.
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