BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BVI

    MDR report key: 17287226 · Received July 10, 2023

    Report

    Report Number
    1211998-2023-00051
    Event Type
    Malfunction
    Date Received
    July 10, 2023
    Date of Event
    June 12, 2023
    Report Date
    July 7, 2023
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL, INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CUSTOMER ALLEGED " LENS IMPLANTED AND EXPLANTED DUE TO COMPROMISED COMPLICATION. WHILE INSERTING THE IOL IN THE BAG, THE LENS SEEMED UNSTABLE, INSPECTING THE POSTERIOR CAPSULE THE IOL WAS THROUGH THE POSTERIOR CAPSULE. AT THAT TIME THE SURGEON EXPLANTED THE IOL AND PROCEEDED TO DO AN ANTERIOR VITRECTOMY. NO PATIENT HARM OCCURRED OR INJURY, SURGEON USED ANOTHER IOL, AND THE POWER WAS CHANGED AS WELL. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804823 BVI IPURE 1 PIECE PRELOADED INTRAOCULAR LENS (CLEAR), +16.50D HQL BEAVER-VISITEC INTERNATIONAL, INC. 6CM80FT7

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown