FDA Adverse Event
Malfunction
Summary report: N
ALCON ACCURUS 25+ GAUGE VITRECTOMY TOTAL PLUS PAK
MDR report key: 2935938
·
Received January 28, 2013
Report
- Report Number
- 2935938
- Event Type
- Malfunction
- Date Received
- January 28, 2013
- Date of Event
- March 12, 2012
- Report Date
- January 28, 2013
- Manufacturer
- ALCON LABORATORIES, INC.
- Product Code
- HQC
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL, US
Narratives
Description of Event or Problem · 1
WHEN THE SURGEON WENT TO PICK UP THE LIGHT PIPE, IT FELL APART IN HER HAND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 38349 | ALCON ACCURUS 25+ GAUGE VITRECTOMY TOTAL PLUS PAK | VITRECTOMY, INSTRUMENT CUTTER, LIGHT CORD | HQC | ALCON LABORATORIES, INC. | * | 12010543X-2012-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |