FDA Adverse Event
Malfunction
Summary report: N
BIOFINITY
MDR report key: 18667601
·
Received February 7, 2024
Report
- Report Number
- MW5151158
- Event Type
- Malfunction
- Date Received
- February 7, 2024
- Date of Event
- January 28, 2024
- Report Date
- February 5, 2024
- Manufacturer
- COOPERVISION INC.
- Product Code
- LPL
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- RP
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
ULCER ON EYE AFTER WEARING CONTACT LENS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1365022 | BIOFINITY | LENSES, SOFT CONTACT, DAILY WEAR | LPL | COOPERVISION INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Prefer Not To Disclose | Other |