PMA P100016S027

Device: CT LUCIA 602, CT LUCIA 202, CT LUCIA 611P, CT LUCIA 621P
Applicant: Carl Zeiss Meditec Production, LLC
PMA number: P100016
Supplement: S027
Product code: HQL
Decision date: 2026-08-17
Classification: Ophthalmic
Generic name: intraocular lens
Approval order statement: implementation of new acceptance criteria for injection testing for R&D and industrialization activities only for CT LUCIA Intraocular Lens (IOLs)

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: S027
Product code: HQL
Generic name: intraocular lens
Decision date: 2026-08-17
Decision code: OK30
Date received: 2026-07-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: implementation of new acceptance criteria for injection testing for R&D and industrialization activities only for CT LUCIA Intraocular Lens (IOLs)