FDA Adverse Event
Malfunction
Summary report: N
BIOFINITY TORIC
MDR report key: 24800418
·
Received April 7, 2026
Report
- Report Number
- MW5186427
- Event Type
- Malfunction
- Date Received
- April 7, 2026
- Date of Event
- April 2, 2026
- Report Date
- April 2, 2026
- Manufacturer
- COOPERVISION INC
- Product Code
- LPM
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
LENS ARE DEFECTIVE AND CONTAIN NO REFRACTION FOR VISION. PATIENT CODE: 4582. DEVICE CODE: 2588, 1631. REFERENCE REPORT MW5186428.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 610772 | BIOFINITY TORIC | LENSES, SOFT CONTACT, EXTENDED WEAR | LPM | COOPERVISION INC | 122335701085260110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male |