BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 4152472 · Received October 6, 2014

    Report

    Report Number
    3003701944-2014-00185
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    February 27, 2014
    Report Date
    September 10, 2014
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: 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. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED FOLLOWING A GLAUCOMA FILTRATION DEVICE PROCEDURE, THE SHUNT WAS TOUCHING THE IRIS. THE SHUNT REMAINS IN THE EYE WITH NO HARM REPORTED TO THE PT. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622156 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR