FDA Adverse Event
Malfunction
Summary report: N
IA HANDPIECE
MDR report key: 28243
·
Received July 19, 1995
Report
- Report Number
- 28243
- Event Type
- Malfunction
- Date Received
- July 19, 1995
- Date of Event
- February 13, 1995
- Report Date
- March 27, 1995
- Manufacturer
- ALLERGAN MEDICAL OPTICS
- Product Code
- HQC
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
AT END OF I/A AND IOL INSERTION 3 FOREIGN BODIES NOTED. NO MOVEMENT UPON IRRIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IA HANDPIECE | HANDPIECE | HQC | ALLERGAN MEDICAL OPTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Other |