BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACARE

    MDR report key: 113556 · Received July 31, 1997

    Report

    Report Number
    MW4001975
    Event Type
    Malfunction
    Date Received
    July 31, 1997
    Date of Event
    July 14, 1997
    Report Date
    July 31, 1997
    Manufacturer
    ALLERGAN MEDICAL OPTICS
    Product Code
    LPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR USED THE PRODUCT AS INDICATED ON THE DIRECTIONS. THAT IS, AFTER CLEANING LENSES WITH SALINE AND DAILY CLEANER, RPTR PLACED THEM IN THE LENS CUP, ADDED DISINFECTION SOLUTION UP TO THE FILL LINE, AND DEPOSITED ONE DISINTENTION TABLET INTO THE CUP. RPTR THEN REPLACED THE CAP TO THE CUP AND PLACED IT IN THE MEDICINE CABINET. THE NEXT MORNING, RPTR WENT TO GET THEIR LENSES AND FOUND THE CUP EMPTY AND THE LID HAD BURST OFF AND WAS ON THE OPPOSITE SIDE OF THE CABINET. THE LENS CUP WAS EMPTY AND RPTR HAS YET TO FIND THEIR CONTACTS. THE MFR SENT RPTR AN E-MAIL DATED 7/29/97 SAYING THAT THEY FORWARDED RPTR'S E-MAIL TO CUSTOMER SVC FOR REVIEW. RPTR HAS YET TO HEAR FROM THEIR REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACARE CONTACT LENS DISINFECTION SOLUTION LPN ALLERGAN MEDICAL OPTICS * 09C20

    Patients

    Seq Age Sex Outcome Treatment
    1 *