- Device
- Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon PanOptix Hydrophobic Acrylic IOL
- Applicant
- Alcon Laboratories, LLC
- PMA number
- P190018
- Supplement
- S014
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2021-12-01
- Decision code
- OK30
- Date received
- 2021-11-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduce Clareon Intraocular Lenses (IOLs) dimensional inspection from 100% to a sampling plan for non-toric models.