BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRUS MICROSTENT

    MDR report key: 21864986 · Received April 18, 2025

    Report

    Report Number
    3016075957-2025-00019
    Event Type
    Injury
    Date Received
    April 18, 2025
    Report Date
    June 27, 2025
    Manufacturer
    IVANTIS INC
    Product Code
    OGO
    PMA / PMN Number
    P170034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: FEA AM, AHMED II, LAVIA C, MITTICA P, CONSOLANDI G, MOTOLESE I, PIGNATA G, MOTOLESE E, ROLLE T, FREZZOTTI P. HYDRUS MICROSTENT COMPARED TO SELECTIVE LASER TRABECULOPLASTY IN PRIMARY OPEN ANGLE GLAUCOMA: ONE YEAR RESULTS. CLIN EXP OPHTHALMOL. 2017 MAR;45(2):120-127. 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 INVESTIGATION SITE FOR EVALUATION FOR THE REPORT OF VITREOUS HEMORRHAGE IN 1 EYE (2.7%) AS PER LITERATURE; 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 REPORTED VIA LITERATURE ARTICLE TO EVALUATE SUCCESS RATE OF TRABECULAR STENT GLAUCOMA PLACEMENT DURING THE INTRODUCTORY PHASE. THIS FILE DESCRIBES ABOUT VITREOUS HEMORRHAGE IN ONE EYE (2.7%). FEA AM, AHMED II, LAVIA C, MITTICA P, CONSOLANDI G, MOTOLESE I, PIGNATA G, MOTOLESE E, ROLLE T, FREZZOTTI P. HYDRUS MICROSTENT COMPARED TO SELECTIVE LASER TRABECULOPLASTY IN PRIMARY OPEN ANGLE GLAUCOMA: ONE YEAR RESULTS. CLIN EXP OPHTHALMOL. 2017 MAR;45(2):120-127.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1732513 HYDRUS MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS INC NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other