- Device
- Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys, Biofinity Toric, Biofinity XR Toric, Biofinity Multifocal; Bio
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S199
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2026-03-18
- Decision code
- OK30
- Date received
- 2026-02-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- introduction of two new osmometers at the CooperVision, Manufacturing, Ltd. facility located in Hamble, United Kingdom