BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRUS MICROSTENT

    MDR report key: 24323627 · Received February 12, 2026

    Report

    Report Number
    3016075957-2026-00006
    Event Type
    Injury
    Date Received
    February 12, 2026
    Report Date
    May 14, 2026
    Manufacturer
    IVANTIS INC
    Product Code
    OGO
    PMA / PMN Number
    P170034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. LITERATURE CITATION: IQBAL IKE K. AHMED, JOHN P. BERDAHL, ARKADIY YADGAROV, GEORGE R. REISS, STEVEN R. SARKISIAN JR., SÉBASTIEN GAGNÉ, MARCO ROBLES, LILIT A. VOSKANYAN, OMAR SADRUDDIN, DARI PARIZADEH, JANE ELLEN GIAMPORCARO, ANGELA C. KOTHE, L. JAY KATZ, TOMAS NAVRATIL. SIX-MONTH OUTCOMES FROM A PROSPECTIVE, RANDOMIZED STUDY OF ISTENT INFINITE VERSUS HYDRUS IN OPEN-ANGLE GLAUCOMA: THE INTEGRITY STUDY. OPHTHALMOL THER (2025) 14: 1005¿1024. 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

    A PHYSICIAN REPORTED VIA LITERATURE ARTICLE TO EVALUATE SIX-MONTH OUTCOMES FROM A PROSPECTIVE, RANDOMIZED STUDY OF ISTENT INFINITE VERSUS HYDRUS IN OPEN-ANGLE GLAUCOMA. THIS FILE PERTAINS TO THE ONE EYE WHICH DID NOT RECEIVE A TRABECULAR STENT DESPITE THREE ATTEMPTS OF PLACEMENT, POSITIONING IN THE SUPRACILIARY SPACE AND IRIS PROLAPSE THAT REQUIRED AN INTRAOPERATIVE IRIDOTOMY. THE SURGEON DECIDED TO ABORT IMPLANTATION. THE FAILED IMPLANTATION ALSO RESULTED IN PAS (PERIPHERAL ANTERIOR SYNECHIAE), FIVE DAYS AFTER SURGERY AND DYSCORIA, THREE WEEKS AFTER SURGERY. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS ONE OF THE THREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478863 HYDRUS MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS INC NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention