BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSTERIOR VICTRECTOMY PACK

    MDR report key: 4870826 · Received June 24, 2015

    Report

    Report Number
    1920664-2015-00094
    Event Type
    Malfunction
    Date Received
    June 24, 2015
    Date of Event
    May 29, 2015
    Report Date
    May 29, 2015
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM A USER FACILITY IN (B)(6) INDICATING THAT DURING THE PROCEDURE, THE CUTTER WAS NOT CUTTING EFFECTIVELY AND THE SURGEON FELT IT WAS PULLING ON THE VITREOUS. THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409625 POSTERIOR VICTRECTOMY PACK 23GACOMB PK W V&AFI&WF 6/BX HQC BAUSCH & LOMB BL5523WV V3857

    Patients

    Seq Age Sex Outcome Treatment
    1