- Device
- Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMe Automated Pre-loaded Delivery System, Clareon Toric Aspheric
- Applicant
- Alcon Laboratories, LLC
- PMA number
- P190018
- Supplement
- S006
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2020-09-29
- Decision code
- OK30
- Date received
- 2020-08-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate supplier for the AutonoMe Delivery System nozzle component (V.3.6).