BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPO-30 PHACO TUBING

    MDR report key: 14743 · Received July 18, 1994

    Report

    Report Number
    MW1002862
    Event Type
    Injury
    Date Received
    July 18, 1994
    Date of Event
    June 1, 1994
    Report Date
    July 14, 1994
    Manufacturer
    ALLERGAN MEDICAL OPTICS
    Product Code
    KYG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MALFUNCTION OF 15 UNITS WITH PROBABLE MALFUNCTION OF 3 MORE UNITS FOR TOTAL OF 18. MOST PROBABLE CAUSE, DEFECTIVE SILICONE TUBING (ALL PARAMETERS OF MULTIPLE PHACO UNITS SHOWED NO MALFUNCTION). PROBLEMS ENCOUNTERED, LITTLE OR NO SUCTION. UNABLE TO PERFORM PHACO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPO-30 PHACO TUBING PHACO TUBING KYG ALLERGAN MEDICAL OPTICS 461MR3

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention