BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRUS MICROSTENT

    MDR report key: 24326449 · Received February 12, 2026

    Report

    Report Number
    3016075957-2026-00012
    Event Type
    Injury
    Date Received
    February 12, 2026
    Report Date
    May 6, 2026
    Manufacturer
    IVANTIS INC
    Product Code
    OGO
    PMA / PMN Number
    P170034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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. TRUBNIK V, HUANG L, HALL B. RETROSPECTIVE STUDY OF TWO-YEAR CLINICAL OUTCOMES OF COMBINATION AB-INTERNO CANALOPLASTY AND A MICROSTENT COMPARED TO AB-INTERNO CANALOPLASTY IN CATARACT SURGERY PATIENTS. CLIN OPHTHALMOL. 2025; 19:1991¿1997. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED VIA LITERATURE ARTICLE TO EVALUATE RETROSPECTIVE STUDY OF TWO YEAR CLINICAL OUTCOMES OF COMBINATION AB INTERNO CANALOPLASTY AND A MICROSTENT COMPARED TO AB INTERNO CANALOPLASTY IN CATARACT SURGERY PATIENTS. THIS FILE IS ABOUT PATIENT REQUIRED SECONDARY SURGICAL INTERVENTION. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 3 OF 3. TRUBNIK V, HUANG L, HALL B. RETROSPECTIVE STUDY OF TWO-YEAR CLINICAL OUTCOMES OF COMBINATION AB-INTERNO CANALOPLASTY AND A MICROSTENT COMPARED TO AB-INTERNO CANALOPLASTY IN CATARACT SURGERY PATIENTS. CLIN OPHTHALMOL. 2025; 19:1991¿1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142603 HYDRUS MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS INC NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention