BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 6422572 · Received March 21, 2017

    Report

    Report Number
    3003701944-2017-00051
    Event Type
    Malfunction
    Date Received
    March 21, 2017
    Report Date
    March 21, 2017
    Manufacturer
    OPTONOL LTD.
    Product Code
    KYF
    PMA / PMN Number
    K012852
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO SAMPLE WAS RETURNED, THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED AND VISUAL INSPECTION CANNOT BE PERFORMED. THE INFORMATION THAT IS CURRENTLY AVAILABLE FOR THE DEVICE LOT/ SERIAL NUMBER IS UNCLEAR; THE REPORTED LOT IS # 072704 , WHILE THE SERIAL NUMBER IS (B)(4). THE DEVICE HISTORY RECORD (DHR) OF LOTS # 72703 AND #72704 WERE REVIEW. NO ABNORMALITIES WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO THE MANUFACTURER'S RELEASE CRITERIA. BECAUSE A SAMPLE WAS NOT RETURNED, AND THE REPORTED PRODUCT LOT / SN IS NOT UNEQUIVOCAL, THE ROOT CAUSE CANNOT BE DETERMINED. THE ROOT CAUSE WILL BE REASSESSED UPON COMPLETING THE INVESTIGATION. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING A GLAUCOMA FILTRATION DEVICE (GFD) IMPLANT PROCEDURE, THE DEVICE DISLODGED PREMATURELY, AND HAD TO BE REMOVED. A DIFFERENT DEVICE WAS IMPLANTED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202796 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. P-50 PL ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other