- Device
- Clareon Vivity Pro Extended Vision IOLs
- Applicant
- Alcon Laboratories, LLC
- PMA number
- P190018
- Supplement
- S050
- Product code
- POE
- Generic name
- Extended depth of focus intraocular lens
- Decision date
- 2026-10-30
- Decision code
- APPR
- Date received
- 2026-05-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for the Clareon Vivity Pro Extended Vision IOLs, Clareon Vivity Pro Extended Vision Toric IOLs, Clareon Vivity Pro Extended Vision UV Absorbing IOL, Clareon Vivity Pro Extended Vision Toric UV Absorbing IOLs, Clareon Vivity Pro Extended Vision IOL with the AutonoMe Pre-loaded Delivery System, Clareon Vivity Pro Extended Vision Toric IOLs with the AutonoMe Pre-loaded Delivery System, Clareon Vivity Pro Extended Vision UV Absorbing IOL with the AutonoMe Pre-loaded Delivery System, and Clareon Vivity Pro Extended Vision Toric UV Absorbing IOLs with the AutonoMe Pre-loaded Delivery System