FDA Adverse Event
Other
Summary report: N
OPERATING MICROSCOPE
MDR report key: 29044
·
Received December 22, 1995
Report
- Report Number
- MW1007982
- Event Type
- Other
- Date Received
- December 22, 1995
- Date of Event
- September 27, 1995
- Report Date
- December 13, 1995
- Manufacturer
- CARL ZEISS, INC.
- Product Code
- HRM
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT HAD CATARACT SURGERY ON THE LEFT EYE COMPLICATED BY A LIMITED CHOROIDAL HEMORRHAGE. THIS CAUSED A DIFFICULT INTRAOCULAR LENS INSERTION AND PROLONGED OPERATING TIME. A RETINAL BURN DUE TO OPERATING MICROSCOPE LIGHT RESULTED. VISION OF LEFT EYE NOW CORRECTABLE TO 20/70-80.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPERATING MICROSCOPE | OPERATING MICROSCOPE | HRM | CARL ZEISS, INC. | Z11P 40735 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Other |