- Device
- Clareon Aspheric Hydrophobic lOL; Clareon PanOptix Hydrophobic lOL; and Clareon Toric Aspheric Hydrophobic lOL
- Applicant
- Alcon Laboratories, LLC
- PMA number
- P190018
- Supplement
- S010
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2021-04-23
- Decision code
- APPR
- Date received
- 2021-02-22
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order 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.