- Device
- Biofinity XR Toric and Biofinity Toric Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S122
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2021-01-15
- Decision code
- OK30
- Date received
- 2020-12-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Increase in the maximum UV cure time on the Biofinity MTO (Made to Order) lines.