BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 5936076 · Received September 8, 2016

    Report

    Report Number
    3003701944-2016-00174
    Event Type
    Injury
    Date Received
    September 8, 2016
    Report Date
    September 8, 2016
    Manufacturer
    OPTONOL LTD.
    Product Code
    KYF
    PMA / PMN Number
    K012852
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED, THE GFD REMAINS IMPLANTED. THE DEVICE HISTORY RECORD (DHR) FOR THE BATCH WAS REVIEWED. NO ABNORMALITIES WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO RELEASE CRITERIA. NO SAMPLE WAS RETURNED, THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. DURING PRODUCTION, 100% FINAL INSPECTION IS BEING PERFORMED ON THE ENTIRE BATCH, INCLUDING VISUAL INSPECTION AND INNER ILLUMINATION. IF A BLOCKAGE WOULD BE NOTICED, THE PRODUCT WOULD HAVE BEEN REJECTED IMMEDIATELY. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION BY PHONE AND EMAIL. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SCRUB TECHNICIAN REPORTED THAT FOLLOWING A GLAUCOMA FILTRATION IMPLANT (GFD) PROCEDURE, THE GFD WAS REMOVED AT A LATER DATE DUE TO IT NOT WORKING. ADDITIONAL INFORMATION WAS PROVIDED BY A DIFFERENT SCRUB TECHNICIAN, WHO REPORTED THAT THE INITIAL GFD WAS LATER FOUND TO NOT BE DRAINING BECAUSE IT WAS PLUGGED UP. APPROXIMATELY, TWO MONTHS LATER THE SURGEON IMPLANTED A SECOND GFD WITHOUT REMOVING THE INITIAL IMPLANT. THE INITIAL GFD REMAINS IMPLANTED. THE SCRUB TECHNICIAN HAS NO FURTHER DETAILS TO PROVIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586823 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. P-50 PL 072527

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| R