PMA P080011S195

Device: Biofmity XR Torie (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S195
Product code: LPM
Decision date: 2026-02-02
Classification: Ophthalmic
Generic name: Lenses, soft contact, extended wear
Approval order statement: introduction of Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear on Biofinity Medium Volume Line 13 at the CooperVision, Inc. facility located in Hamble, UK

Current openFDA PMA Record#

Device: Biofmity XR Torie (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S195
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2026-02-02
Decision code: OK30
Date received: 2026-01-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: introduction of Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear on Biofinity Medium Volume Line 13 at the CooperVision, Inc. facility located in Hamble, UK