PMA P190018S048

Device: Clareon Aspheric Hydrophobic Acrylic IOL (SY60WF); Clareon Aspheric UV Absorbing IOL (CC60WF); Clareon Toric Aspheric UV
Applicant: Alcon Laboratories, LLC
PMA number: P190018
Supplement: S048
Product code: HQL
Decision date: 2026-04-30
Classification: Ophthalmic
Generic name: intraocular lens
Approval order statement: approval application (PMA) 180-day supplement, which requested approval for a new packaging configuration, automation of the primary and secondary packaging processes, and updates to shelf-life and storage conditions of the AcrySof IOLs (storage condition temperatures from 45 °C to 30 °C), and Clareon IOLs (to extend the shelf life from four (4) years to five (5) years at the temperature of 30 °C) in Alcon’s manufacturing facilities in West Virginia, USA and Cork, Ireland.

Current openFDA PMA Record#

Device: Clareon Aspheric Hydrophobic Acrylic IOL (SY60WF); Clareon Aspheric UV Absorbing IOL (CC60WF); Clareon Toric Aspheric UV
Applicant: Alcon Laboratories, LLC
PMA number: P190018
Supplement: S048
Product code: HQL
Generic name: intraocular lens
Decision date: 2026-04-30
Decision code: APPR
Date received: 2026-01-30
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval application (PMA) 180-day supplement, which requested approval for a new packaging configuration, automation of the primary and secondary packaging processes, and updates to shelf-life and storage conditions of the AcrySof IOLs (storage condition temperatures from 45 °C to 30 °C), and Clareon IOLs (to extend the shelf life from four (4) years to five (5) years at the temperature of 30 °C) in Alcon’s manufacturing facilities in West Virginia, USA and Cork, Ireland.