FDA Adverse Event
Malfunction
Summary report: N
MICRO INCISION VACUUM PACK
MDR report key: 4223642
·
Received August 5, 2014
Report
- Report Number
- 1920664-2014-00162
- Event Type
- Malfunction
- Date Received
- August 5, 2014
- Date of Event
- July 7, 2014
- Report Date
- July 7, 2014
- Manufacturer
- BAUSCH & LOMB, INC.
- Product Code
- HQC
- PMA / PMN Number
- K063331
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER STATED THIS IS A RECURRENT INCIDENT; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE. DEVICE HAS BEEN REQUESTED FOR EVALUATION HOWEVER IT HAS NOT YET ARRIVED. STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND NO EXCEPTIONS WERE FOUND.
Description of Event or Problem · 1
A REPORT WAS RECEIVED FROM A USER FACILITY IN FRANCE STATING: "DURING A CATARACT SURGERY WITH A RELATIVELY HARD NUCLEUS THE FILTER OF THE STABLE CHAMBER CLOGGED AND ASPIRATION NO LONGER WORKED. THE SURGICAL PROCEDURE WAS INTERRUPTED. THIS TYPE OF INCIDENT INCREASES THE QUANTITY OF ULTRASOUNDS DELIVERED AND REQUIRES THE CASSETTE EXCHANGE THUS EXTENDING SURGICAL TIME."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 458441 | MICRO INCISION VACUUM PACK | STELLARIS ANTERIOR SYSTEM | HQC | BAUSCH & LOMB, INC. | BL5113 | V2520 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |