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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 Toric II Intraocular Lens (IOL) With TECNIS Simplicity Delivery System, Models DRT150, DRT225, DRT300, DR
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS159
Date Received06/13/2023
Decision Date12/22/2023
Product Code HQL 
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 the TECNIS Odyssey Toric II Intraocular Lens (IOL) with TECNIS Simplicity Delivery System, Models DRT150, DRT225, DRT300, DRT375.
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