PMA approvals

Clareon Vivity Pro Extended Vision IOLs

Alcon Laboratories, LLC · Extended depth of focus intraocular lens · Ophthalmic

P190018 S050SupplementApproved
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
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.