FDA Adverse Event
Malfunction
Summary report: N
STELLARIS OPTIMIZED STABILITY VACUUM PACK
MDR report key: 2191049
·
Received July 19, 2011
Report
- Report Number
- 1920664-2011-00094
- Event Type
- Malfunction
- Date Received
- July 19, 2011
- Date of Event
- June 20, 2011
- Report Date
- June 20, 2011
- Manufacturer
- BAUSCH & LOMB
- Product Code
- HQC
- PMA / PMN Number
- K063331
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT HAS BEEN REQUESTED FOR EVALUATION; HOWEVER; IT IS UNKNOWN IF IT WILL BE RETURNED.
Description of Event or Problem · 1
REPORT RECEIVED FROM (B)(4) STATES: "DURING STELLARIS POSTERIOR CHAMBER DEMO, THE CUTTER WAS WORKING IN THE BEGINNING OF THE LIST, DURING THE LIST, THE CUTTER FAILED TO CUT AT 4000 CUTS. NEW PACK OPENED TO USE A NEW CUTTER. NO MEDICAL INTERVENTION WAS REQUIRED." ADDITIONAL INFORMATION HAS BEEN REQUESTED YET NOT RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STELLARIS OPTIMIZED STABILITY VACUUM PACK | HQC | BAUSCH & LOMB | Y4735 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | STELLARIS EQUIPMENT (BAUSCH + LOMB) |