PMA P080011S200

Device: Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys, Biofinity Toric, Biofinity XR Toric, Biofinity Multifocal; Bio
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S200
Product code: LPM
Decision date: 2026-04-09
Classification: Ophthalmic
Generic name: Lenses, soft contact, extended wear
Approval order statement: Conversion of the de-ionized water dosing system from manual to fully automated at the CooperVision, Manufacturing, Ltd. facility located in Hamble, United Kingdom.

Current openFDA PMA Record#

Device: Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys, Biofinity Toric, Biofinity XR Toric, Biofinity Multifocal; Bio
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S200
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2026-04-09
Decision code: OK30
Date received: 2026-03-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Conversion of the de-ionized water dosing system from manual to fully automated at the CooperVision, Manufacturing, Ltd. facility located in Hamble, United Kingdom.