PMA P080011S140

Device: Biofinity Sphere and Biofinity XR Sphere, Biofinity Toric and Biofinity XR Toric, Biofinity Energys, Biofinity Multifoca
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S140
Product code: LPM
Decision date: 2022-04-14
Generic name: Lenses, soft contact, extended wear
Approval order statement: Updates to the software used in the Wet Automated Inspection System for the Biofinity Automated Wet Lines at the CooperVision Manufacturing facility in Hamble UK.

Current openFDA PMA Record#

Device: Biofinity Sphere and Biofinity XR Sphere, Biofinity Toric and Biofinity XR Toric, Biofinity Energys, Biofinity Multifoca
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S140
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2022-04-14
Decision code: OK30
Date received: 2022-03-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Updates to the software used in the Wet Automated Inspection System for the Biofinity Automated Wet Lines at the CooperVision Manufacturing facility in Hamble UK.