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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™ IOL with TECNIS Simplicity™ Delivery System, Model DIB00, TECNIS Eyhance™ Toric II IOLs with TECNIS Simp
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS155
Date Received11/18/2022
Decision Date12/12/2022
Product Code HQL 
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  
Adding an alternate manufacturing and sterilization site at AMO Groningen B.V., Van Swietenlaan 5, Groningen, The Netherlands 9728NX for TECNISEyhance IOL with TECNIS Simplicity Delivery System, Model DIB00, and TECNIS Eyhance Toric II IOLs with TECNIS Simplicity Delivery System, Models DIU150-600.
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