BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLAUCOMA PRESSURE REGULATOR

    MDR report key: 10937 · Received January 10, 1994

    Report

    Report Number
    MW1000372
    Event Type
    Injury
    Date Received
    January 10, 1994
    Date of Event
    November 30, 1993
    Report Date
    December 28, 1993
    Manufacturer
    OPTIMED
    Product Code
    KYF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    11/2/93 GLAUCOMA PRESSURE REGULATOR INSTILLED OS FOR SEVERE ANGLE CLOSURE GLAUCOMA WITH PREVIOUS FAILED FILTER AND SCARRING. PRESSURE NOT CONTROLLED WITH IOP OF 40 AGAIN BY 11/16/93. MEDICINE INADEQUATE TO CONTROL PRESSURE. GPR REMOVED 11/30/93 AND REPLACED WITH DOUBLE PLATE SHUNT. PRESSURE HAS BEEN GOOD SINCE REPLACED. INTRAOPERATIVELY SCAR WAS FOUND SURROUNDING DISTAL GPF END AND PREVENTED FLOW. TUBE WAS PATENT ONCE EXTRACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLAUCOMA PRESSURE REGULATOR Implant KYF OPTIMED OGPR - T

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention