PMA P080011S192

Device: Biofinity Toric Multifocal and Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S192
Product code: LPM
Decision date: 2025-09-22
Classification: Ophthalmic
Generic name: Lenses, soft contact, extended wear
Approval order statement: introduction of a collation and packaging machine at the CooperVision, Inc. facility located in Scottsville, NY

Current openFDA PMA Record#

Device: Biofinity Toric Multifocal and Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S192
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2025-09-22
Decision code: OK30
Date received: 2025-08-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: introduction of a collation and packaging machine at the CooperVision, Inc. facility located in Scottsville, NY