Premarket Approval (PMA)

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.

• Device: CT LUCIA 602, CT LUCIA 202
• Generic Name: intraocular lens
• Regulation Number: 886.3600
• Applicant: Carl Zeiss Meditec Production, LLC; 1040 S. Vintage Ave., Bldg. A; Ontario, CA 91761
• PMA Number: P100016
• Supplement Number: S019
• Date Received: 09/15/2023
• Decision Date: 10/10/2023
• Product Code: HQL
• Advisory Committee: Ophthalmic
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
a modification of the heparin fixture