BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRUS MICROSTENT

    MDR report key: 12047047 · Received June 22, 2021

    Report

    Report Number
    3016075957-2021-00028
    Event Type
    Injury
    Date Received
    June 22, 2021
    Report Date
    June 22, 2021
    Manufacturer
    IVANTIS, INC.
    Product Code
    OGO
    UDI-DI
    00867487000134
    PMA / PMN Number
    P170034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HYDRUS MICROSTENT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR EVALUATION. DEVICE IDENTIFIERS WERE REQUESTED, BUT WERE NOT PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ANY NEW INFORMATION BECOMES AVAILABLE. PERSISTENT IRITIS AND MICROSTENT MOVEMENT ARE LISTED IN THE DEVICE LABELING AS POTENTIAL ADVERSE EVENTS. MANUFACTURER REFERENCE #: CMP (B)(4).

    Description of Event or Problem · 1

    A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT UNEVENTFUL CATARACT SURGERY WITH IMPLANTATION OF THE HYDRUS MICROSTENT IN THE LEFT EYE ON (B)(6) 2020. THE SURGEON PLANNED TO EXPLANT THE HYDRUS MICROSTENT DUE TO PERSISTENT IRITIS, BUT THE PATIENT IS REQUESTING A SECOND OPINION. THE SURGEON ALSO REPORTED THE MICROSTENT APPEARS TO BE SLOWLY MOVING OUT OF SCHLEMM'S CANAL AND THE IRIS IS NOW PEAKED TOWARDS THE MICROSTENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO UNDERSTAND THE HEALTH EFFECT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942441 HYDRUS MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS, INC. F00022 00867487000134

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention