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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.
 
DeviceCT LUCIA 602, CT LUCIA 202, CT LUCIA 611P, CT LUCIA 621P
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantCarl Zeiss Meditec Production, LLC
1040 S. Vintage Ave., Bldg. A
Ontario, CA 91761
PMA NumberP100016
Supplement NumberS027
Date Received07/23/2026
Decision Date08/17/2026
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  
implementation of new acceptance criteria for injection testing for R&D and industrialization activities only for CT LUCIA Intraocular Lens (IOLs)
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