BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 10265957 · Received July 13, 2020

    Report

    Report Number
    3003701944-2020-00030
    Event Type
    Injury
    Date Received
    July 13, 2020
    Report Date
    July 13, 2020
    Manufacturer
    OPTONOL LTD.
    Product Code
    KYF
    PMA / PMN Number
    K012852
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: COMPLAINT HISTORY AND PRODUCT HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A VALID LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED IN A LITERATURE ARTICLE TITLED "REOPERATION RATES AFTER EX-PRESS VERSUS TRABECULECTOMY FOR PRIMARY OPEN ANGLE OR NORMAL TENSION GLAUCOMA: A NATIONAL DATABASE STUDY IN JAPAN" THAT THE EX-PRESS (GFD) IMPLANTATION HAD SIGNIFICANTLY HIGHER REOPERATION RATES AND GREATER COST THAN TRABECULECTOMY. A RETROSPECTIVE COHORT STUDY USING NATIONAL INPATIENT DATABASE IN JAPAN WAS PERFORMED. PATIENTS AGED 18 TO 85 YEARS WITH PRIMARY OPEN ANGLE OR NORMAL TENSION GLAUCOMA WHO UNDERWENT GFD IMPLANTATION OR TRABECULECTOMY FROM 2010 TO 2017, WERE INCLUDED. TOTAL HOSPITALIZATION COSTS BETWEEN THE TWO TREATMENTS WERE ALSO COMPARED. THE REOPERATION RATES WERE 7.6% FOR THE GFD GROUP AND 5.8% FOR THE TRABECULECTOMY. THE MOST FREQUENTLY PERFORMED TYPE OF REOPERATION WAS TRABECULECTOMY IN BOTH GROUPS. HOWEVER, WHETHER THE GFD OR TRABECULECTOMY IS SUPERIOR IN TERMS OF REOPERATION RATES REMAINS UNKNOWN. THE GFD IMPLANTATION HAD SIGNIFICANTLY HIGHER REOPERATION RATES AND GREATER COST THAN TRABECULECTOMY. GFD AND TRABECULECTOMY REPORTEDLY HAVE SIMILAR EFFICACY AND SAFETY PROFILES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728595 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. P-50 PL ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention