BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 3812591 · Received May 7, 2014

    Report

    Report Number
    3003701944-2014-00072
    Event Type
    Injury
    Date Received
    May 7, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 9, 2014
    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: NO DATA REGARDING PRODUCT IDENTIFY 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. BECAUSE A SAMPLE WAS NOT RETURNED, THE ROOT CAUSE CANNOT BE DETERMINED. THE SURGEON WAS UNWILLING TO PROVIDE FURTHER INFO. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THREE MONTHS AFTER A GLAUCOMA FILTERING SHUNT WAS IMPLANTED, THE PATIENT'S INTRAOCULAR PRESSURE INCREASED. THE SURGEON REPORTED THAT IT SEEMED THE LUMEN OF THE SHUNT WAS CLOGGED BY BROWN MATERIAL SUCH AS IRIS OR BLOOD. SURGICAL INTERVENTION IS BEING CONSIDERED, BUT IS NOT YET PLANNED. THE SURGEON WAS UNWILLING TO PROVIDE FURTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276665 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other