FDA Adverse Event
Malfunction
Summary report: N
MICO INCISION VACUUM PACK
MDR report key: 4924379
·
Received July 16, 2015
Report
- Report Number
- 1920664-2015-00122
- Event Type
- Malfunction
- Date Received
- July 16, 2015
- Date of Event
- June 22, 2015
- Report Date
- June 22, 2015
- Manufacturer
- BAUSCH & LOMB, INC.
- Product Code
- HQC
- PMA / PMN Number
- K063331
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS BEEN REQUESTED FOR EVALUATION HOWEVER IT HAS NOT YET BEEN RECEIVED. STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND NO EXCEPTIONS WERE FOUND. THIS REPORT IS RELATED TO THE EVENT REPORTED ON MDR 1920664-2015-00123.
Description of Event or Problem · 1
A REPORT WAS RECEIVED FROM A USER FACILITY IN (B)(6) STATING: "CLOGGED FILTER DURING THE PHACO. NO PATIENT IMPACT. PRODUCT REQUEST".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 463780 | MICO INCISION VACUUM PACK | HQC | BAUSCH & LOMB, INC. | V4051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |