FDA Adverse Event
Malfunction
Summary report: N
STELLARIS PREMIUM PHACO VACUUM PACK
MDR report key: 2193262
·
Received July 13, 2011
Report
- Report Number
- 1920664-2011-00088
- Event Type
- Malfunction
- Date Received
- July 13, 2011
- Date of Event
- May 17, 2011
- Report Date
- June 16, 2011
- Manufacturer
- BAUSCH & LOMB
- Product Code
- HQC
- PMA / PMN Number
- K063331
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS BEEN REQUESTED TO BE RETURNED; HOWEVER, IT HAS NOT BEEN RECEIVED.
Description of Event or Problem · 1
REPORT RECEIVED FROM (B)(6) WHICH STATES: "THE ANTERIOR CHAMBER WAS UNSTABLE, THE PROBLEM WAS SOLVED BY REPLACING THE CASSETTE. THE SURGEON FOUND THE ANTERIOR CHAMBER COLLAPSED WHEN STEPPING DOWN ON THE FOOTPEDAL (TO ACTIVATE VACUUM) EVEN THE BOTTLE HEIGHT WAS ADJUSTED HIGHER THAN NORMAL. MOST LIKELY THE CASSETTE COULDN'T PROVIDE ENOUGH IRRIGATION. THE SURGEON SPENT MORE THAN FIVE MINUTES TO INVESTIGATE THE ISSUE AND THE NURSE SPENT MORE THAN SIX MINUTES TO REPLACE AND PRIME THE CASSETTE, TOTAL TIME DELAY IS ELEVEN MINUTES. NO PHYSICAL IMPACT TO THE PT. THE SURGERY ENDED WITH THE EXPECTED RESULTS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STELLARIS PREMIUM PHACO VACUUM PACK | HQC | BAUSCH & LOMB | U5760 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | STELLARIS EQUIPMENT (BAUSCH + LOMB) |