FDA Adverse Event
Injury
Summary report: N
STELLARIS PREMIUM VACUUM PHACO PACK
MDR report key: 1960996
·
Received January 11, 2011
Report
- Report Number
- 1920664-2011-00002
- Event Type
- Injury
- Date Received
- January 11, 2011
- Date of Event
- December 2, 2010
- Report Date
- December 13, 2010
- Manufacturer
- BAUSCH & LOMB
- Product Code
- HQC
- PMA / PMN Number
- P603331
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
A DEVICE HISTORY RECORD REVIEW HAS BEEN INITIATED AND THE RESULTS WILL BE RELAYED IN A SUBSEQUENT REPORT.
Description of Event or Problem · 1
DURING QUADRANT REMOVAL OF HARD CATARACT, THE IRRIGATION STOPPED AND AS A RESULT THE PT'S ANTERIOR CHAMBER COLLAPSED. AFTER CHANGING THE TUBING, THE SAME INCIDENT OCCURRED. ACCORDING TO PROVIDED INFO, THE SURGERY WAS AFTERWARDS COMPLETED SUCCESSFULLY. ADD'L INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STELLARIS PREMIUM VACUUM PHACO PACK | HQC | BAUSCH & LOMB | U4656 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |