PMA P080011S196

Device: Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S196
Product code: LPM
Decision date: 2026-02-10
Classification: Ophthalmic
Generic name: Lenses, soft contact, extended wear
Approval order statement: implementation of a new process for machining Biofinity Sphere and Biofinity Toric optical inserts produced at the Insert Shop at the CooperVision, Inc. facility located in Juana Diaz, Puerto Rico

Current openFDA PMA Record#

Device: Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S196
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2026-02-10
Decision code: OK30
Date received: 2026-01-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: implementation of a new process for machining Biofinity Sphere and Biofinity Toric optical inserts produced at the Insert Shop at the CooperVision, Inc. facility located in Juana Diaz, Puerto Rico