Clareon Vivity Pro Extended Vision IOLs
Alcon Laboratories, LLC · Extended depth of focus intraocular lens · Ophthalmic
Open FDA's page for this record- PMA number
- P190018
- Supplement number
- S050
- Applicant
- Alcon Laboratories, LLC
- Street 1
- 6201 S. Fwy.
- City
- Fort Worth
- State
- TX
- Zip
- 76134
- Generic name
- Extended depth of focus intraocular lens
- Trade name
- Clareon Vivity Pro Extended Vision IOLs
- Product code
- POE
- Advisory committee
- OP
- Advisory committee description
- Ophthalmic
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Expedited review flag
- N
- Date received
- 2026-05-14
- Decision date
- 2026-10-30
- Decision code
- APPR
- Ao 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
- Harmonized identifiers (openFDA)
- Device name
- Extended Depth Of Focus Intraocular Lens
- Medical specialty description
- Ophthalmic
- Regulation number
- 886.3600
- Device class
- 3
- Registration number
- 3015456951, 9612169, 3017636737, 1610287, 2648035, 9614546, 1119279, 3010173425, 3002807314, 1119421, 3016942176, 9681121, 3007530141, 3012236936, 1313525, 3010155661
- FEI number
- 3015456951, 3017636737, 1610287, 2648035, 1317628, 3002807036, 3004651700, 3002807944, 1119279, 3002807314, 1119421, 3016942176, 3007530141, 3012236936, 3002808262, 3010155661
