PMA P190018S046

Device: Clareon Vivity™ Toric Extended Vision UV Absorbing Hydrophobic Intraocular Lens (IOL)
Applicant: Alcon Laboratories, LLC
PMA number: P190018
Supplement: S046
Product code: HQL
Decision date: 2026-05-15
Classification: Ophthalmic
Generic name: intraocular lens
Approval order statement: approval for expanding the range for Clareon Vivity™ Toric Extended Vision UV Absorbing Hydrophobic IOLs in the lens case configuration to include 4.50 D (CNWET7/CCWET7), 5.25 D (CNWET8/CCWET8), and 6.0 D (CNWET9/CCWET9) cylindrical power models.

Current openFDA PMA Record#

Device: Clareon Vivity™ Toric Extended Vision UV Absorbing Hydrophobic Intraocular Lens (IOL)
Applicant: Alcon Laboratories, LLC
PMA number: P190018
Supplement: S046
Product code: HQL
Generic name: intraocular lens
Decision date: 2026-05-15
Decision code: APPR
Date received: 2025-11-10
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for expanding the range for Clareon Vivity™ Toric Extended Vision UV Absorbing Hydrophobic IOLs in the lens case configuration to include 4.50 D (CNWET7/CCWET7), 5.25 D (CNWET8/CCWET8), and 6.0 D (CNWET9/CCWET9) cylindrical power models.