BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISTENT INJECT W TRABECULAR MICRO-BYPASS SYSTEM

    MDR report key: 25096838 · Received May 6, 2026

    Report

    Report Number
    2032546-2026-00038
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 23, 2026
    Manufacturer
    GLAUKOS CORPORATION
    Product Code
    OGO
    PMA / PMN Number
    P170043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A2, A3, B6, B7: MEAN AND MODE USED. B3: PUBLICATION DATE USED AS EVENT DATE. THE DEVICES WERE NOT AVAILABLE; THEREFORE, PRODUCT TESTING ON THE ACTUAL DEVICES COULD NOT BE PERFORMED. THE DEVICE IDENTIFIERS WERE NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS FOR THESE DEVICE LOT NUMBERS COULD NOT BE REVIEWED. A REVIEW OF THE DEVICE LABELING AND ASSOCIATED RISK DOCUMENTS WAS COMPLETED. STENT OBSTRUCTION IS IDENTIFIED AS A KNOWN INHERENT RISK OF TRABECULAR MICRO-BYPASS STENT PROCEDURE. THE IFU ADEQUATELY PROVIDES INSTRUCTIONS FOR STENT IMPLANTATION, PRECAUTIONS, AND WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. THE REPORTED EVENTS ARE ESTABLISHED RISKS ASSOCIATED WITH USE OF THE DEVICES, WHICH IS CLEARLY DOCUMENTED. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE OF THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY IDENTIFIED. MFR# REFERENCE: (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED THROUGH A REVIEW OF THE ARTICLE TITLED, "CLINICAL OUTCOMES OF TRABECULAR MICRO-BYPASS STENT IN PATIENTS WITH MODERATE TO SEVERE OPEN ANGLE GLAUCOMA". REPORTEDLY FOLLOWING TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURES IN A TOTAL OF TWENTY-TWO (22) OPERATIVE EYES, "IRIS PLUGGING" OCCURRED IN TWO (2) OPERATIVE EYES. ADDITIONAL INFORMATION HAS BEEN REQUESTED. PLEASE SEE ATTACHED ARTICLE FOR FURTHER DETAILS. REFERENCE DOI: 10.3341/KJO.2026.0015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445046 ISTENT INJECT W TRABECULAR MICRO-BYPASS SYSTEM INTRAOCULAR PRESSURE LOWERING IMPLANT OGO GLAUKOS CORPORATION G2-W

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female