FDA Adverse Event
Malfunction
Summary report: N
ALLERGAN
MDR report key: 294691
·
Received June 28, 2000
Report
- Report Number
- MW1019846
- Event Type
- Malfunction
- Date Received
- June 28, 2000
- Date of Event
- April 26, 2000
- Report Date
- June 28, 2000
- Manufacturer
- ALLERGAN MEDICAL OPTICS ZEISS HUMPHREY SYSTEMS
- Product Code
- HQC
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DURING PHACOEMULSIFCATION OF CATARACT, THE ALLERGAN PHACO MACHINE DID NOT WORK IN VITRECTOMY MODE. CASE COMPLETED WITH ANOTHER MACHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALLERGAN | PHACO MACHINE | HQC | ALLERGAN MEDICAL OPTICS ZEISS HUMPHREY SYSTEMS | SOVERIGN | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR |