PMA P080011S193

Device: Biofinity XR Toric and Biofinity Toric Multifocal (Comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S193
Product code: LPM
Decision date: 2025-12-11
Classification: Ophthalmic
Generic name: Lenses, soft contact, extended wear
Approval order statement: installation and qualification of an upgraded purified water system at the CooperVision, Inc. facility located in Scottsville, NY

Current openFDA PMA Record#

Device: Biofinity XR Toric and Biofinity Toric Multifocal (Comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S193
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2025-12-11
Decision code: OK30
Date received: 2025-10-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: installation and qualification of an upgraded purified water system at the CooperVision, Inc. facility located in Scottsville, NY