- Device
- Biornedics 55 Asphere and Biornedies Torie (Ocuftlcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear
- Applicant
- The Cooper Companies
- PMA number
- P890023
- Supplement
- S056
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2025-12-11
- Decision code
- OK30
- Date received
- 2025-10-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- installation and qualification of an upgraded purified water system at the CooperVision, Inc. facility located in Scottsville, NY