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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 Intraocular Lenses (IOLs)
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantCarl Zeiss Meditec Production, LLC
1040 S. Vintage Ave., Bldg. A
Ontario, CA 91761
PMA NumberP100016
Supplement NumberS028
Date Received09/28/2026
Decision Date10/23/2026
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  
changes to the tray raw material and lid coating for CT LUCIA 621P Intraocular lens (IOL) and a sterilization process change involving the removal of the ambient aeration step from the Ethylene Oxide (EO) sterilization process for CT LUCIA 202, CT LUCIA 602, and CT LUCIA 621P IOLs
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