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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 Odyssey IOL with TECNIS SIMPLICITY Delivery System (DRN00V); TECNIS Odyssey Toric II IOLs with TECNIS SIMPLICITY
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS174
Date Received06/13/2025
Decision Date09/11/2025
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a change in the endotoxin specification limit for preloaded intraocular lens storage/delivery systems to harmonize this limit with the relevant intraocular device ISO Standard and FDA Guidance.
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