FDA Adverse Event
Other
Summary report: N
ZEISS OPMI 6CFC MICROSCOPE
MDR report key: 37038
·
Received August 2, 1996
Report
- Report Number
- 37038
- Event Type
- Other
- Date Received
- August 2, 1996
- Date of Event
- May 1, 1996
- Report Date
- May 9, 1996
- Manufacturer
- SURGICAL PRODUCTS DIV., CARL ZEISS, INC.
- Product Code
- HRM
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- NY, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE PT UNDERWENT A RIGHT PHACOEMULSIFICATION WITH POSTERIOR CHAMBER INTRAOCULAR LENS IMPLANT. FOLLOWING THE PROCEDURE THE PT WAS SEEN BY HER OPHTHALMOLOGIST AND A DIAGNOSIS OF RETINAL BURN WAS MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZEISS OPMI 6CFC MICROSCOPE | MICROSCOPE | HRM | SURGICAL PRODUCTS DIV., CARL ZEISS, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Other |