BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 21445403 · Received February 24, 2025

    Report

    Report Number
    3003701944-2025-00002
    Event Type
    Injury
    Date Received
    February 24, 2025
    Date of Event
    January 1, 2025
    Report Date
    May 20, 2025
    Manufacturer
    OPTONOL LTD.
    Product Code
    KYF
    PMA / PMN Number
    K012852
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    505

    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. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED IN H3, H6 AND H11. A SAMPLE WAS NOT RECEIVED AT THE INVESTIGATION SITE FOR EVALUATION FOR THE REPORT OF RATHER HIGH OCULAR TONE VALUES AND INTERVENE WITH A SPECIAL LASER; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. A LOT NUMBER WAS IDENTIFIED, HOWEVER IS NOT A VALID LOT NUMBER THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED. THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Description of Event or Problem · 0

    A NON HCP REPORTED ABOUT HIGH OCULAR TONE VALUES (AROUND 25) DETECTED AFTER IMPLANTATION OF GLAUCOMA SHUNT. THE REPORTER SUSPECT OF A PARTIAL OCCLUSION OF THE SHUNT. THE REPORTER ADDITIONALLY ENQUIRED ABOUT WHETHER THE DEVICE EQUIPPED WITH AN ACCESSORY ORIFICE ON WHICH THE OPHTHALMOLOGIST CAN INTERVENE WITH A SPECIAL LASER. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THERE WERE NO BLOCKAGES BUT THE SURGERY WAS CONSIDERED TO BE PARTIALLY SUCCESSFUL DUE TO PATIENT CURRENTLY USING CARBONIC ANHYDRASE INHIBITOR WITH BETA BLOCKER AND PROSTAGLANDIN ANALOGUE DROPS TWICE A DAY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404883 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. NI 133814

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention AZARGA 10 MG+5 TWICE A DAY AND BIMADOC 0.3 ONCE