FDA Adverse Event
Malfunction
Summary report: N
STORZ INSTRUMENT CO
MDR report key: 60141
·
Received December 27, 1996
Report
- Report Number
- 1920664-1996-00942
- Event Type
- Malfunction
- Date Received
- December 27, 1996
- Date of Event
- November 26, 1996
- Report Date
- November 26, 1996
- Manufacturer
- STORZ INSTRUMENT CO.
- Product Code
- HQC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE COULD NOT BE CALIBRATED. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STORZ INSTRUMENT CO | PHACOEMULSIFICATION HANDPIECE | HQC | STORZ INSTRUMENT CO. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |