BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO INCISION VACUUM PACK

    MDR report key: 3221845 · Received July 9, 2013

    Report

    Report Number
    1920664-2013-00173
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 14, 2013
    Report Date
    June 11, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQC
    PMA / PMN Number
    K063331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) THAT DURING A PHACO PROCEDURE AT THE EARLY SEGMENT REMOVAL OF A SOFT NUCLEUS, THE FILTER BECAME CLOGGED. THE SURGEON USED ANOTHER PACK TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313607 MICRO INCISION VACUUM PACK HQC BAUSCH & LOMB U9907

    Patients

    Seq Age Sex Outcome Treatment
    1 STELLARIS EQUIPMENT (BAUSCH + LOMB)