Clareon Intraocular Lenses with the AutonoMe Delivery System
FDA premarket approval P190018/S008 · decided 2020-11-24
Approval details
- PMA number
- P190018
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Clareon Intraocular Lenses with the AutonoMe Delivery System
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, LLC
- Date received
- 2020-10-30
- Decision date
- 2020-11-24
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Implementation of new optical metrology equipment, Gen-3 MTF System, to be used as part of the manufacturing process for Clareon PanOptix Intraocular Lenses at the Alcon Ireland manufacturing site.
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