BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRUS MICROSTENT

    MDR report key: 23255826 · Received October 9, 2025

    Report

    Report Number
    3016075957-2025-00053
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    July 29, 2025
    Report Date
    January 6, 2026
    Manufacturer
    IVANTIS INC
    Product Code
    OGO
    PMA / PMN Number
    P170034
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED IN H.3, H.6. AND H.11. A SAMPLE WAS NOT RECEIVED AT THE INVESTIGATION SITE FOR EVALUATION FOR THE REPORT OF HMS PROLAPSE THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. THE REPORTED PRODUCT¿S LOT NUMBER WAS NOT REPORTED, PREVENTING LOT NUMBER SPECIFIC REVIEWS FOR SIMILAR COMPLAINTS OR NONCONFORMANCES. HOWEVER, BEFORE PRODUCTION RELEASE, EACH PRODUCT HISTORY RECORD IS REVIEWED TO ENSURE THAT ALL ASSOCIATED PRODUCTS MEET THE REQUIRED SPECIFICATIONS AND RELEASE CRITERIA. BASED ON THE EVALUATION OF THE INFORMATION AND MATERIALS RECEIVED, THE INVESTIGATION WAS UNABLE TO IDENTIFY THE ROOT CAUSE OR ORIGIN OF THE REPORTED EVENT. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED IN B.3., B.5., D.6A AND D.7A. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT INTRAOPERATIVE FINDINGS DID NOT INDICATE STENT PROLAPSE. HYPHEMA HAD BEEN PRESENT DURING SURGERY. GONIOSCOPY HAD REVEALED A TIP PROLAPSE, WHICH HAD NOT BEEN DETECTED BY SLIT LAMP EXAMINATION. NO REOPERATION WAS PERFORMED, AND THE PATIENT REMAINED UNDER OBSERVATION, WITH NO CLEAR INCREASE IN INTRAOCULAR PRESSURE.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF TRABECULAR MICROSTENT PROLAPSE. THERE ARE SEVENTEEN MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 10 OF 17.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2509155 HYDRUS MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS INC NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown