Zeiss 3-piece Hydrophobic Acrylic Intraocular lens (IOL)
FDA premarket approval P100016/S007 · decided 2021-05-13
Approval details
- PMA number
- P100016
- Supplement
- S007
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Zeiss 3-piece Hydrophobic Acrylic Intraocular lens (IOL)
- Generic name
- intraocular lens
- Applicant
- Carl Zeiss Meditec Production, LLC
- Date received
- 2020-08-31
- Decision date
- 2021-05-13
- Days to decision
- 255 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- 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.
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