PMA P100016S023

Device: CT LUCIA 602; CT LUCIA 202; CT LUCIA 611P; CT LUCIA 621P
Applicant: Carl Zeiss Meditec Production, LLC
PMA number: P100016
Supplement: S023
Product code: HQL
Decision date: 2026-03-20
Classification: Ophthalmic
Generic name: intraocular lens
Approval order statement: a change in the heated aeration room used for the aeration phase of the routine Ethylene Oxide (EO) sterilization process, and dissipation of EO sterilant residuals, for product sterilized in Chamber #1 at the existing sterilization site

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: S023
Product code: HQL
Generic name: intraocular lens
Decision date: 2026-03-20
Decision code: APPR
Date received: 2025-11-17
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a change in the heated aeration room used for the aeration phase of the routine Ethylene Oxide (EO) sterilization process, and dissipation of EO sterilant residuals, for product sterilized in Chamber #1 at the existing sterilization site