BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAOCULAR PRESSURE LOWERING IMPLANT

    MDR report key: 8717688 · Received June 20, 2019

    Report

    Report Number
    2032546-2019-00095
    Event Type
    Injury
    Date Received
    June 20, 2019
    Report Date
    August 1, 2019
    Manufacturer
    GLAUKOS CORPORATION
    Product Code
    OGO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, G3. MFR# REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5 CORRECTION D1: XEN GLAUCOMA TREATMENT SYSTEM, D2: KYF/IMPLANT, EYE VALVE, D3: ALLERGAN BASED ON INFORMATION RECEIVED, GLAUKOS CORPORATION IS NO LONGER ASSOCIATING THIS REPORTED EVENT WITH TRABECULAR MICRO BYPASS STENT. MFR# REFERENCE: (B)(4).

    Description of Event or Problem · 0

    THROUGH SOCIAL MEDIA MONITORING, THE PATIENT REPORTED THE FOLLOWING ADDITIONAL INFORMATION. REPORTEDLY, THE PRESSURE STILL ¿HIGH¿ DUE TO SCAR TISSUES. NO FURTHER DETAILS WERE PROVIDED.

    Description of Event or Problem · 0

    THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM PATIENT ON 07/13/2019 IN FOLLOW-UP TO SOCIAL MEDIA POSTING. THE PATIENT REPORTED THEY HAD A GEL STENT INSERTED INTO THE RIGHT EYE A COUPLE MONTHS AGO. REPORTEDLY, THE PATIENT HAD SCAR TISSUE REMOVAL AND CONTINUES TO HAVE HIGH PRESSURE SECONDARY TO SCARRING AND THAT THE SURGEON WANTS TO IMPLANT ANOTHER STENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE; THEREFORE, PRODUCT TESTING ON THE ACTUAL DEVICE COULD NOT BE PERFORMED. THE DEVICE IDENTIFIERS WERE NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS AND COMPLAINT HISTORY RECORDS FOR THIS DEVICE LOT NUMBER COULD NOT BE REVIEWED. A REVIEW OF THE DEVICE LABELING WAS COMPLETED. ELEVATED IOP IS IDENTIFIED IN THE LABELING AS A KNOWN INHERENT RISK OF TRABECULAR MICRO-BYPASS STENT/CATARACT PROCEDURE. THE IFU ADEQUATELY PROVIDES INSTRUCTIONS FOR STENT IMPLANTATION, PRECAUTIONS, AND WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. THE DECISION TO REPORT WAS BASED ON LACK OF SUFFICIENT INFORMATION. MFR REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    THROUGH SOCIAL MEDIA MONITORING, A TRABECULAR MICRO BYPASS STENT PATIENT REPORTED THAT "THE PRESSURE KEEPS GOING UP" FOLLOWING CATARACT PLUS STENT PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE PATIENT AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512219 INTRAOCULAR PRESSURE LOWERING IMPLANT OGO GLAUKOS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other