FDA Adverse Event
Malfunction
Summary report: N
AMVISC PLUS
MDR report key: 448784
·
Received March 11, 2003
Report
- Report Number
- MW4003475
- Event Type
- Malfunction
- Date Received
- March 11, 2003
- Manufacturer
- BAUSCH AND LOMB PHARMACEUTICALS INC
- Product Code
- LZP
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
A SMALL BLACK (OR DARK BLUE) FIBER APPROX 5MM IN LENGTH CAME OUT OF TUBE OF AMVISC PLUS DURING MID INJECTION INTO THE ANTERIOR CHAMBER. IT WAS IDENTIFIED AND REMOVED WITHOUT APPARENT COMPLICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMVISC PLUS | * | LZP | BAUSCH AND LOMB PHARMACEUTICALS INC | * | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |