FDA Adverse Event
Malfunction
Summary report: N
TOTAL PLUS PACK 23 GAUGE
MDR report key: 1586379
·
Received January 13, 2010
Report
- Report Number
- 1586379
- Event Type
- Malfunction
- Date Received
- January 13, 2010
- Date of Event
- January 12, 2010
- Report Date
- January 13, 2010
- Manufacturer
- ALCON LABORATORIES, INC.
- Product Code
- MLZ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- RI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE SURGEON WAS PERFORMING A VITRECTOMY. THE VITRECTOMY CUTTER BECAME STUCK IN THE CANNULA AND FORCE WAS NEEDED TO REMOVE IT. A NEW CANNULA WAS PLACED THROUGH THE PRE-EXISTING SCLEROTOMY. IT WAS NOTED THAT THERE WAS A PERIPHERAL RETINAL DETACHMENT. AN ENDO LASER CRYOPEXY AND PFO AIR FLUID EXCHANGE WERE NEEDED TO ADDRESS THE DETACHED RETINA. MANUFACTURER RESPONSE (AS PER REPORTER) FOR 23 GAUGE OCCUTONE, TOTAL PLUS PACK 23 GAUGE;NOT KNOWN AT THIS TIME
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTAL PLUS PACK 23 GAUGE | 23 GAUGE OCCUTONE | MLZ | ALCON LABORATORIES, INC. | 8065750828 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |