BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 20219461 · Received September 14, 2024

    Report

    Report Number
    3003701944-2024-00043
    Event Type
    Injury
    Date Received
    September 14, 2024
    Report Date
    December 9, 2024
    Manufacturer
    OPTONOL LTD.
    Product Code
    KYF
    PMA / PMN Number
    K012852
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. LITERATURE ARTICLE: YAMAZAKI, H. ET AL., COMPARISON OF CORNEAL ENDOTHELIAL CELL DENSITY REDUCTION BETWEEN PRIMARY OPEN ANGLE GLAUCOMA AND PSEUDO EXFOLIATION GLAUCOMA PATIENTS AT 3 YEARS AFTER EX PRESS SURGERY. INT OPHTHALMOL. 23 JULY 2024; 44:333. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN H.3., H.6. AND H.11. A SAMPLE WAS NOT RECEIVED AT INVESTIGATION SITE FOR EVALUATION FOR THE REPORT OF CORNEAL ENDOTHELIAL CELL DENSITY DECREASED AFTER THE SURGERY AND YTTRIUM ALUMINUM GARNET (YAG); 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. A SAMPLE WAS NOT RECEIVED AT THE INVESTIGATION SITE AND NO LOT INFORMATION IS AVAILABLE, 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 SURGEON REPORTED THAT FOLLOWING A GLAUCOMA SHUNT IMPLANT PROCEDURE, THE DEVICE WAS OCCLUDED. YAG LASER WAS PERFORMED FOR OCCLUSION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209373 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. P-50 PL ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention