- Device
- Zeiss 3-piece Hydrophobic Acrylic Intraocular lens (IOL)
- Applicant
- Carl Zeiss Meditec Production, LLC
- PMA number
- P100016
- Supplement
- S007
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2021-05-13
- Decision code
- APPR
- Date received
- 2020-08-31
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for changes in manufacturing with installation of new equipment and process accessories for machining, tumbling, assembly, and inspection for 3-piece intraocular lens models CT LUCIA 202 and CT LUCIA 602.