Clareon Aspheric Hydrophobic lOL; Clareon PanOptix Hydrophobic lOL; and Clareon Toric Aspheric Hydrophobic lOL
FDA premarket approval P190018/S010 · decided 2021-04-23
Approval details
- PMA number
- P190018
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Clareon Aspheric Hydrophobic lOL; Clareon PanOptix Hydrophobic lOL; and Clareon Toric Aspheric Hydrophobic lOL
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, LLC
- Date received
- 2021-02-22
- Decision date
- 2021-04-23
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for new manufacturing facilities located at Alcon Research, LLC, AODC-South, 6065 Kyle Lane, Huntington, WV 25702 and Alcon Research, LLC, AODC-North, 2 Vision Lane, Lesage, WV.
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