PMA P080011S194

Device: comfilcon A Soft (Hydrophilic) Contact Lenses for daily wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S194
Product code: LPM
Decision date: 2026-01-07
Classification: Ophthalmic
Generic name: Lenses, soft contact, extended wear
Approval order statement: modification of the Programmable Logic Controller (PLC) for a packaging line at the Cooper Vision, Inc. facility located in Mountpark, UK

Current openFDA PMA Record#

Device: comfilcon A Soft (Hydrophilic) Contact Lenses for daily wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S194
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2026-01-07
Decision code: OK30
Date received: 2025-12-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: modification of the Programmable Logic Controller (PLC) for a packaging line at the Cooper Vision, Inc. facility located in Mountpark, UK