FDA Adverse Event
Malfunction
Summary report: N
ALCON ACCURUS 25+ GAUGE VITRECTOMY TOTAL PLUS PAK
MDR report key: 2931794
·
Received January 22, 2013
Report
- Report Number
- 2931794
- Event Type
- Malfunction
- Date Received
- January 22, 2013
- Date of Event
- May 9, 2012
- Report Date
- January 22, 2013
- Manufacturer
- ALCON
- Product Code
- MLZ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL, US
Narratives
Description of Event or Problem · 1
LIGHT PIPE WAS "FLICKERING," WOULD NOT STAY ON CONTINUOUSLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30612 | ALCON ACCURUS 25+ GAUGE VITRECTOMY TOTAL PLUS PAK | VITRECTOMY, INSTRUMENT CUTTER | MLZ | ALCON | * | 12611786H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR |