FDA Adverse Event
Malfunction
Summary report: N
STELLARIS OPTIMIZED STABILITY VACUUM PACK
MDR report key: 2101956
·
Received May 18, 2011
Report
- Report Number
- 1920664-2011-00033
- Event Type
- Malfunction
- Date Received
- May 18, 2011
- Date of Event
- April 19, 2011
- Report Date
- April 19, 2011
- Manufacturer
- BAUSCH & LOMB
- Product Code
- HQC
- PMA / PMN Number
- P063331
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND NO EXCEPTIONS WERE FOUND.
Description of Event or Problem · 1
REPORT RECEIVED FROM (B)(6) STATES: "USED IN COMBINED PROCEDURE. FUNCTIONING WELL UP TO 5000CPM. SURGEON REMOVED CUTTER, APPROXIMATELY TWENTY MINUTES LATER REINSERTED AT WHICH TIME CUTTER DID NOT CUT VITREOUS THUS CAUSING TRACTION ON RETINA (CUTTER WAS NOT BENT). CUTTER WAS REPLACED TO CONTINUE THE PROCEDURE." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STELLARIS OPTIMIZED STABILITY VACUUM PACK | HQC | BAUSCH & LOMB | U4705 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | STELLARIS EQUIPMENT (BAUSCH + LOMB) |