PMA P080011S197

Device: Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S197
Product code: LPM
Decision date: 2026-03-04
Classification: Ophthalmic
Generic name: Lenses, soft contact, extended wear
Approval order statement: the introduction of Biofinity Toric on Biofinity Dry Line 13 at the CooperVision, Inc. facility located in Hamble, United Kingdom

Current openFDA PMA Record#

Device: Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S197
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2026-03-04
Decision code: OK30
Date received: 2026-02-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the introduction of Biofinity Toric on Biofinity Dry Line 13 at the CooperVision, Inc. facility located in Hamble, United Kingdom