PMA P190018S045

Device: Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon PanOptix Hydrophobic Acrylic IOL
Applicant: Alcon Laboratories, LLC
PMA number: P190018
Supplement: S045
Product code: HQL
Decision date: 2025-12-12
Classification: Ophthalmic
Generic name: intraocular lens
Approval order statement: approval of a new cleanroom (Controlled Environment (CE)) for Intraocular lenses manufactured at Alcon Huntington, West Virginia

Current openFDA PMA Record#

Device: Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon PanOptix Hydrophobic Acrylic IOL
Applicant: Alcon Laboratories, LLC
PMA number: P190018
Supplement: S045
Product code: HQL
Generic name: intraocular lens
Decision date: 2025-12-12
Decision code: OK30
Date received: 2025-11-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval of a new cleanroom (Controlled Environment (CE)) for Intraocular lenses manufactured at Alcon Huntington, West Virginia