- Device
- Clareon Vivity™ Extended Vision Hydrophobic Intraocular Lens (IOL), Clareon Vivity™ Toric Extended Vision Hydrophobic IO
- Applicant
- Alcon Laboratories, LLC
- PMA number
- P190018
- Supplement
- S013
- Product code
- POE
- Generic name
- Extended depth of focus intraocular lens
- Decision date
- 2022-01-26
- Decision code
- APPR
- Date received
- 2021-10-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Clareon Vivity Extended Vision Hydrophobic IOL and the Clareon Vivity Toric Extended Vision Hydrophobic IOL in lens case and AutonoMe Automated Pre-loaded Delivery System configurations.