- Device
- Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon PanOptix Hydrophobic Acrylic IOL
- Applicant
- Alcon Laboratories, LLC
- PMA number
- P190018
- Supplement
- S016
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2021-12-22
- Decision code
- OK30
- Date received
- 2021-11-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduction of the Clareon Intraocular Lenses (IOLs) plan view inspection from a 100% inspection to a statistical sampling plan in Alcon Ireland facility.