BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMVISC

    MDR report key: 2172464 · Received June 24, 2011

    Report

    Report Number
    2031924-2011-00117
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 27, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    LZP
    PMA / PMN Number
    P810025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE. THE RELATED PRODUCTS HAVE BEEN REQUESTED, HAVE NOT BEEN RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CATARACT SURGERY, THE CANNULA FROM A VISCOELASTIC DEVICE CAME LOOSE DURING INJECTION AND SHOT OFF THE HUB INTO THE PT'S EYE. THERE WAS NO INJURY TO THE PT. ACCORDING TO THE INFO RECEIVED, THE NURSING STAFF WAS UNABLE TO TIGHTEN THE CANNULA INTO PLACE; THIS OCCURRED WITH A TOTAL OF TWO UNITS DURING THE SURGERY AND WITH TWO OTHER UNITS AFTER SURGERY WITHOUT PT CONTACT. ALL FOUR UNITS WERE FROM THE SAME LOT NUMBER 023640.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMVISC VISCOELASTIC LZP BAUSCH & LOMB 59081L 023640

    Patients

    Seq Age Sex Outcome Treatment
    1