BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BVI

    MDR report key: 17394168 · Received July 25, 2023

    Report

    Report Number
    1211998-2023-00052
    Event Type
    Malfunction
    Date Received
    July 25, 2023
    Date of Event
    June 19, 2023
    Report Date
    July 25, 2023
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL, INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    SURGEON ALLEGED "AFTER IMPLANTING THE IOL INTO THE PATIENTS EYE NOTICE THE FRONT HAPTIC WAS SHEARED OFF, WHERE THE BLUE TIP OF THE HAPTIC MEETS CLEAR ACRYLIC, LENS WAS LEFT IMPLANTED IN PATIENTS EYE. SURGEON LEFT THE LENS IN PATIENTS EYE AND NOT REMOVE, WILL CONTINUE TO MONITOR FOR ROTATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1839420 BVI IPURE 1 PIECE PRELOADED INTRAOCULAR LENS (CLEAR), +21.50D HQL BEAVER-VISITEC INTERNATIONAL, INC. 6CM90DYA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention