- Device
- CT LUCIA Intraocular Lenses (IOLs)
- Applicant
- Carl Zeiss Meditec Production, LLC
- PMA number
- P100016
- Supplement
- S028
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2026-10-23
- Decision code
- OK30
- Date received
- 2026-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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