BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO INCISION VACUUM PHACO PACK

    MDR report key: 4022795 · Received July 10, 2014

    Report

    Report Number
    1920664-2014-00124
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 10, 2014
    Manufacturer
    BAUSCH & LOMB
    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

    THE FACILITY HAS DISCARDED THE PRODUCT, IT IS NOT AVAILABLE FOR EVAL. STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND NO EXCEPTIONS WERE FOUND. THIS REPORT IS RELATED TO THE EVENT REPORTED ON MDR 1920664-2014-00125, 00126, 00127 AND 00128.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM A USER FACILITY IN (B)(4) STATING: "SLEEVE DEFECTIVE, DOES NOT PASS THRU A 2.2 INCISION. NO PRODUCT RETURNED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405448 MICRO INCISION VACUUM PHACO PACK HQC BAUSCH & LOMB BL5114 V2664

    Patients

    Seq Age Sex Outcome Treatment
    1