BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRUS® MICROSTENT

    MDR report key: 14116035 · Received April 14, 2022

    Report

    Report Number
    3016075957-2022-00026
    Event Type
    Injury
    Date Received
    April 14, 2022
    Date of Event
    February 1, 2022
    Report Date
    April 14, 2022
    Manufacturer
    IVANTIS INC.
    Product Code
    OGO
    UDI-DI
    00867487000134
    PMA / PMN Number
    P170034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE LOT NUMBER IS UNKNOWN; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS WAS UNABLE TO BE PERFORMED. IT IS PRESUMED THAT THE MICROSTENT REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED FROM THE LEAD AUTHOR BUT WAS NOT AVAILABLE. ELEVATED IOP, PERIPHERAL ANTERIOR SYNECHIAE, CORNEAL EDEMA, AND SECONDARY SURGICAL INTERVENTION ARE LISTED IN THE DEVICE LABELING AS POTENTIAL ADVERSE EVENTS. THE CASE OF MALIGNANT GLAUCOMA WITH ASSOCIATED MYOPIC SHIFT, ELEVATED IOP, AND CORNEAL EDEMA WERE NOT CORRELATED TO THE HYDRUS MICROSTENT BY THE INTERNATIONAL PANEL OF SIX SURGEONS CONSULTING ON THE CASE. REFERENCE: FRAM NR, BEDROOD S, DURR GM, ET AL. A MYSTERIOUS MYOPIC SURPRISE. J CATARACT REFRACT SURG. 2022;48(2):254. DOI:10.1097/J.JCRS.0000000000000882. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED THROUGH A REVIEW OF A LITERATURE FOR A CONSULTATION CASE TITLED, "A MYSTERIOUS MYOPIC SURPRISE." A PATIENT WITH A HISTORY OF CHRONIC ANGLE-CLOSURE GLAUCOMA UNDERWENT FEMTOSECOND LASER-ASSISTED CATARACT SURGERY WITH HYDRUS IMPLANTATION ON AN UNKNOWN DATE. TWO MONTHS POST-OPERATIVELY, THE PATIENT WAS REFERRED FOR A MYOPIC SURPRISE WITH UNCORRECTED VA OF 20/80 (CORRECTABLE TO 20/25), AND IOP WAS 26MMHG (ON 2 IOP-LOWERING MEDICATIONS). ULTRASOUND BIOMICROSCOPY CONFIRMED THE DIAGNOSIS OF MALIGNANT GLAUCOMA. THE PATIENT UNDERWENT REPEAT LASER PERIPHERAL IRIDOTOMY, AND REQUIRED SUBSEQUENT IRIDOZONULOHYALOIDECTOMY (IZH) VITRECTOMY AND GONIOSYNECHIALYSIS. AFTER TREATMENT, THE MYOPIC REFRACTIVE SHIFT RESOLVED AND AT 1-MONTH POST-OPERATIVE EXAMINATION, THE IOP WAS 12MMHG. SIX SURGEONS CONSULTED ON THIS PUBLISHED CASE REPORT AND THERE WERE NO COMMENTS OR INDICATIONS THAT THE HYDRUS MICROSTENT WAS CORRELATED WITH THIS REPORTED CASE OF MALIGNANT GLAUCOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2658933 HYDRUS® MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS INC. F00022 00867487000134

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention