PMA P190018S051

Device: Clareon Aspheric Hydrophobic Acrylic Intraocular Lens with the AutonoMe Pre- Loaded Delivery System, Clareon Toric Asphe
Applicant: Alcon Laboratories, LLC
PMA number: P190018
Supplement: S051
Product code: HQL
Decision date: 2026-08-17
Classification: Ophthalmic
Generic name: intraocular lens
Approval order statement: approval for a new packaging configuration, automation of the primary and secondary packaging processes, and updates to shelf-life and storage conditions of the Clareon IOLs (to extend the shelf life from three (3) and four (4) years to five (5) years at the temperature of 30 °C) at the Cork, Ireland manufacturing facility

Current openFDA PMA Record#

Device: Clareon Aspheric Hydrophobic Acrylic Intraocular Lens with the AutonoMe Pre- Loaded Delivery System, Clareon Toric Asphe
Applicant: Alcon Laboratories, LLC
PMA number: P190018
Supplement: S051
Product code: HQL
Generic name: intraocular lens
Decision date: 2026-08-17
Decision code: APPR
Date received: 2026-05-21
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for a new packaging configuration, automation of the primary and secondary packaging processes, and updates to shelf-life and storage conditions of the Clareon IOLs (to extend the shelf life from three (3) and four (4) years to five (5) years at the temperature of 30 °C) at the Cork, Ireland manufacturing facility