BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISTENT TRABECULAR MICRO-BYPASS

    MDR report key: 3872110 · Received April 17, 2014

    Report

    Report Number
    2032546-2014-00012
    Event Type
    Injury
    Date Received
    April 17, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    GLAUKOS CORPORATION
    Product Code
    OGO
    PMA / PMN Number
    P080030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PATIENT AND IS NOT AVAILABLE FOR EVALUATION. NO DEVICE IDENTIFIERS ARE AVAILABLE AT THIS TIME. IRIS DAMAGE AND HYPHEMA ARE LISTED IN THE DEVICE LABELING AS KNOWN INHERENT RISKS OF GLAUCOMA STENT SURGERY. MRF REFERENCE #: (B)(4). SUBMITTED TO FDA ON 04/17/2014.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT DURING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE ISTENT, THE STENT WAS POSITIONED SUPERFICIALLY. WHEN REGRASPING THE STENT IN AN ATTEMPT TO REPOSITION IT, HE INADVERTENTLY GRABBED THE IRIS, RESULTING IN HYPHEMA AND IRIDODIALYSIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235045 ISTENT TRABECULAR MICRO-BYPASS INTRAOCULAR PRESSURE LOWERING IMPLANT OGO GLAUKOS CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other