BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL PHACOEMULSIFICATION PACK

    MDR report key: 577132 · Received February 18, 2005

    Report

    Report Number
    1920664-2005-00037
    Event Type
    Malfunction
    Date Received
    February 18, 2005
    Date of Event
    November 16, 2004
    Report Date
    January 19, 2005
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A VITRECTOMY PROCEDURE, THE CUTTER FROM THIS VITRECTOMY PACK WOULD NTO CUT THE VITREOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL PHACOEMULSIFICATION PACK BASIC POSTERIOR PACK WITH REFLUX HQC BAUSCH & LOMB, INC. NA T2224

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN