PMA P080011S143

Device: Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys, and Biofinity Multifocal (comfilcon A) Soft (Hydrophilic) Cont
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S143
Product code: LPM
Decision date: 2022-04-27
Generic name: Lenses, soft contact, extended wear
Approval order statement: Extension of Lens Transfer II process to include non-toric Biofinity cast-moulded products at the CooperVision Manufacturing, Ltd. facility in Hamble, United Kingdom.

Current openFDA PMA Record#

Device: Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys, and Biofinity Multifocal (comfilcon A) Soft (Hydrophilic) Cont
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S143
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2022-04-27
Decision code: OK30
Date received: 2022-03-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Extension of Lens Transfer II process to include non-toric Biofinity cast-moulded products at the CooperVision Manufacturing, Ltd. facility in Hamble, United Kingdom.