BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 3682750 · Received March 5, 2014

    Report

    Report Number
    3003701944-2014-00019
    Event Type
    Injury
    Date Received
    March 5, 2014
    Date of Event
    January 1, 2014
    Report Date
    February 3, 2014
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DATA REGARDING PRODUCT IDENTITY WAS RECEIVED I.E. NO LOT OR SERIAL NUMBER WERE INDICATED FOR THE EVENT; THEREFORE, THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. NO SAMPLE WAS RETURNED, THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. THE ROOT CAUSE CANNOT BE DETERMINED. CITATION: C MARIOTTI, E DAHAN, M NICOLAI, L LEVITZ AND S BOUEE. LONG-TERM OUTCOMES AND RISK FACTORS FOR FAILURE WITH THE EX-PRESS GLAUCOMA DRAINAGE DEVICE. EYE (2014) 28, 1-8. (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE THE INVESTIGATORS REPORTED THAT TWO PATIENTS (0.8%) DEVELOPED A BLEB LEAK AFTER A GLAUCOMA FILTRATION SHUNT IMPLANT SURGERY THAT REQUIRED A BLEB REVISION. THIS IS THE THIRD OF THREE REPORTS BEING FILED FOR THIS LITERATURE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132901 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention