FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION LXT
MDR report key: 2034392
·
Received March 15, 2011
Report
- Report Number
- 2034392
- Event Type
- Malfunction
- Date Received
- March 15, 2011
- Date of Event
- March 3, 2011
- Report Date
- March 15, 2011
- Manufacturer
- ALCON
- Product Code
- HQC
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
SYSTEM SHUT DOWN ON ITS OWN. LOST POWER BRIEFLY DURING USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSTELLATION LXT | MICROSURGERY DEVICE | HQC | ALCON | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | NO OTHER THERAPIES |