BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 3221787 · Received July 9, 2013

    Report

    Report Number
    3003701944-2013-00054
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 13, 2013
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO SAMPLE WAS RETURNED, THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED AND VISUAL INSPECTION CANNOT BE PERFORMED. THE ROOT CAUSE CANNOT BE DETERMINED AND NO ACTIONS ARE TAKEN. NO OTHER COMPLAINTS HAVE BEEN REPORTED IN THE LOT. THE CONSUMER'S HUSBAND DECLINED TO PROVIDE FOLLOW UP INFORMATION FOR THE SURGEON, SO NO FOLLOW UP COULD BE PERFORMED FOR THE SURGEON. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER'S HUSBAND REPORTED A GLAUCOMA FILTRATION SHUNT WAS IMPLANTED INTO THE RIGHT EYE OF HIS WIFE. AFTER THE SURGERY, HIS WIFE'S RESULTS HAVE BEEN IMPROVED, THE INTRAOCULAR PRESSURE (IOL) HAD BEEN DECREASED. DURING THE WEEK PRIOR TO THIS REPORT, SHE EXPERIENCED VISUAL IMPAIRMENT AND WENT TO THE OPHTHALMOLOGIST. THE TESTS SHOWED THAT THE IOP WAS HIGH AGAIN. A FEW DAYS LATER, THE IOP WAS MEASURED AGAIN, AND THE RESULT WAS AROUND 20 MMHG, BUT ON THE NEXT DAY, IT WAS HIGH AGAIN. THE CONSUMER'S HUSBAND DECLINED TO PROVIDE FOLLOW UP INFORMATION FOR THE SURGEON, SO NO FOLLOW UP COULD BE PERFORMED FOR THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312413 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50PL 122231

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DIAMOX TBL (ACETAZOLAMIDE)| KALDYUM (600 MG POTASSIUM CHLORIDE)