FDA Adverse Event
Other
Summary report: N
LEGACY SERIES 2000
MDR report key: 500584
·
Received October 27, 2003
Report
- Report Number
- 500584
- Event Type
- Other
- Date Received
- October 27, 2003
- Date of Event
- July 1, 2003
- Report Date
- August 1, 2003
- Manufacturer
- ALCON LABORATORIES, INC.
- Product Code
- HQC
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
AFTER SCULPTING THE LENS OF THE RIGHT EYE, THE PHYSICAN SWITCHED TO BIOMODAL ON THE LEGACY CATERACT MACHINE. AT THIS TIME THE PHYSICIAN FELT THAT A SURGE OF FLUID ENTERED THE EYE. THE EQUIPMENT WAS IMPOUNDED AND TAKEN OUT OF SERVICE FOR FURTHER EXAMINATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEGACY SERIES 2000 | CATARACT MACHINE | HQC | ALCON LABORATORIES, INC. | LEGACY 2000 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Other |