BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 2875145 · Received December 12, 2012

    Report

    Report Number
    3003701944-2012-00084
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 12, 2012
    Manufacturer
    OPTONOL LTD.
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED. NO ABNORMALITIES WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO RELEASE CRITERIA. ALL PRODUCTS PASS 100% FINAL INSPECTION. THE SHUNT'S LUMEN APPEARED TO BE CLEAR, WITH NO BLOCKAGE. THE COMPLAINANT STATEMENT "CLOGGED" COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED AND DOES NOT SEEM TO BE DEVICE RELATED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT'S INTRAOCULAR PRESSURE (IOP) TO BE INCREASING FOLLOWING SHUNT IMPLANTATION. THE PATIENT UNDERWENT YAG LASER TREATMENT AND THE IOP DECREASED TEMPORARILY. HOWEVER, THE IOP INCREASED AGAIN. SUBSEQUENTLY, THE SHUNT WAS EXPLANTED AND A TRABECULECTOMY WAS PERFORMED ONE WEEK THEREAFTER. THE SURGEON BELIEVES THE SHUNT WAS CLOGGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL LTD. P-50 PL 121605

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention