BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAOCULAR PRESSURE LOWERING IMPLANT

    MDR report key: 9643024 · Received January 29, 2020

    Report

    Report Number
    2032546-2020-00013
    Event Type
    Malfunction
    Date Received
    January 29, 2020
    Date of Event
    January 9, 2020
    Report Date
    March 12, 2020
    Manufacturer
    GLAUKOS CORPORATION
    Product Code
    OGO
    UDI-DI
    00853704002272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MFR# REFERENCE: (B)(4).

    Description of Event or Problem · 0

    THROUGH FOLLOW-UP, THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. REPORTEDLY, THE STENT WAS INTRAOPERATIVELY IMPLANTED LOOSE IN THE TRABECULAR MESHWORK (TM) WHICH CONTRIBUTED TO THE REPORTED EVENT. THE STENT REMAINS IN THE CAPSULAR BAG WITHOUT ANY ADVERSE IMPACTS TO THE PATIENT. THE SURGEON PLANS TO MONITOR THE POSITIONING OF THE STENT. THE MOST RECENT PROGNOSIS WAS REPORTED AS ¿EVERYTHING IS FINE, NO HANDICAP WITH THE STENT IN THE CAPSULAR BAG WITH ADVERSE EVENT RESOLVED¿.

    Additional Manufacturer Narrative · 1

    THE STENT WAS NOT IMPLANTED IN THE PROPER LOCATION, BUT REMAINS IN THE PATIENT'S EYE THEREFORE THE SURGERY DATE WAS INDICATED IN THE IMPLANT DATE FIELD. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION; THEREFORE TESTING ON THE ACTUAL DEVICE COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS MANUFACTURING LOT AND THERE WERE NO NON-CONFORMITIES FOUND TO BE RELATED TO THE REPORTED EVENT. A REVIEW OF THE DEVICE LABELING WAS COMPLETED. MALPOSITION STENT IS IDENTIFIED IN THE LABELING AS A KNOWN INHERENT RISK OF TRABECULAR MICRO-BYPASS STENT SURGERY. THE IFU ADEQUATELY PROVIDES INSTRUCTIONS FOR STENT IMPLANTATION, PRECAUTIONS, AND WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. THIS DEVICE IS NOT CURRENTLY APPROVED FOR MARKETING IN THE US, BUT WAS REPORTED BASED ON SIMILARITY WITH THE APPROVED DEVICE MODEL G2-M-IS (PMA# P170043). MFR REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING IMPLANTATION OF 2 STENTS FROM THE TRABECULAR MICRO BYPASS STENT SYSTEM, DURING REMOVAL OF VISCOELASTIC FROM THE ANTERIOR CHAMBER OF THE RIGHT EYE WITH IRRIGATION AND ASPIRATION, 1 STENT WAS FLUSHED BEHIND THE IOL INTO THE CAPSULAR BAG. THE IMPLANT WAS UNABLE TO BE REMOVED AND REMAINS IN THE CAPSULAR BAG. IT WAS NOTED THAT THE IRIS WAS VERY NARROW DUE TO MIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106150 INTRAOCULAR PRESSURE LOWERING IMPLANT OGO GLAUKOS CORPORATION 126208 00853704002272

    Patients

    Seq Age Sex Outcome Treatment
    1