BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRUS MICROSTENT

    MDR report key: 21535573 · Received March 6, 2025

    Report

    Report Number
    3016075957-2025-00010
    Event Type
    Injury
    Date Received
    March 6, 2025
    Report Date
    May 29, 2025
    Manufacturer
    IVANTIS INC
    Product Code
    OGO
    PMA / PMN Number
    P170034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HONG Z, JOINER DW, ATIK A. REMOVAL OF HYDRUS MICROSTENT DUE TO UVEITIS-GLAUCOMA-HYPHEMA SYNDROME. J FR OPHTALMOL. 2023 APR; 46(4): 413. 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).

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS NOT RECEIVED AT THE INVESTIGATION SITE FOR EVALUATION FOR THE REPORT OF VISUAL ACUITY WAS 20/80, INTRAOCULAR PRESSURE WAS 34 MMHG, IRISTRANSILLUMINATION DEFECT, REMOVAL OF THE HMS, PULLING THROUGH THE TRABECULAR MESHWORK, AND RIGHT EYE DISCOMFORT SIX MONTHS AFTER CATARACT SURGERY; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED. THEREFORE, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL VIA LITERATURE ARTICLE REPORTED THAT AFTER A STENT IMPLANT PROCEDURE PATIENT HAD PRESENTED WITH PERSISTENT RIGHT EYE DISCOMFORT SIX MONTHS AFTER CATARACT SURGERY. ON EXAMINATION, VISUAL ACUITY WAS 20/80 AND INTRAOCULAR PRESSURE WAS 34 MMHG. THERE WAS 2+ RED AND WHITE BLOOD CELLS IN THE ANTERIOR CHAMBER AND A LINEAR IRIS TRANSILLUMINATION DEFECT CONSISTENT WITH THE OUTER EDGE OF AN INCOMPLETELY IMPLANTED STENT. REMOVAL OF THE STENT WAS PERFORMED WITH A PERIBULBAR BLOCK. AN UNSUCCESSFUL ATTEMPT WAS MADE TO REMOVE THE STENT IN THE DIRECTION OF ITS INITIAL INSERTION. THE STENT WAS THUS REMOVED BY PULLING THROUGH THE TRABECULAR MESHWORK, RESULTING IN A LIMITED TRABECULOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536480 HYDRUS MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS INC NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention| O