PMA P100016

Device: CT LUCIA 602, CT LUCIA 202, CT LUCIA 611P, CT LUCIA 621P
Applicant: Carl Zeiss Meditec Production, LLC
PMA number: P100016
Supplement: S015
Product code: HQL
Decision date: 2026-06-10
Generic name: intraocular lens
Approval order statement: adding an alternate supplier of a raw material utilized in the composition of the adhesive used to manufacture three-piece intraocular lens (CT LUCIA 202 and CT LUCIA 602)

Current openFDA PMA Record#

Device: CT LUCIA 602, CT LUCIA 202, CT LUCIA 611P, CT LUCIA 621P
Applicant: Carl Zeiss Meditec Production, LLC
PMA number: P100016
Supplement: S025
Product code: HQL
Generic name: intraocular lens
Decision date: 2026-06-10
Decision code: OK30
Date received: 2026-05-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: adding an alternate supplier of a raw material utilized in the composition of the adhesive used to manufacture three-piece intraocular lens (CT LUCIA 202 and CT LUCIA 602)