- Device
- Biofinity XR Toric and Biofinity Toric Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended wear
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S152
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2022-12-21
- Decision code
- OK30
- Date received
- 2022-11-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Software update to the Biofinity made to order line at the CooperVision Manufacturing, Ltd. facility in Hamble, United Kingdom.