PMA P080011S201

Device: Biofinity Sphere; Biofinity XR Sphere; Biofinity Energys; Biofinity Toric; Biofinity XR Toric; Biofinity Multifocal
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S201
Product code: LPM
Decision date: 2026-05-04
Classification: Ophthalmic
Generic name: Lenses, soft contact, extended wear
Approval order statement: introduction of a Syncro Lens Packaging Machine at the CooperVision, Inc. facility located in West Henrietta, New York

Current openFDA PMA Record#

Device: Biofinity Sphere; Biofinity XR Sphere; Biofinity Energys; Biofinity Toric; Biofinity XR Toric; Biofinity Multifocal
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S201
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2026-05-04
Decision code: OK30
Date received: 2026-04-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: introduction of a Syncro Lens Packaging Machine at the CooperVision, Inc. facility located in West Henrietta, New York