BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPURE

    MDR report key: 17741178 · Received September 13, 2023

    Report

    Report Number
    1211998-2023-00054
    Event Type
    Injury
    Date Received
    September 13, 2023
    Date of Event
    August 7, 2023
    Report Date
    September 12, 2023
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL, INC.
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CUSTUMER ALLEGED THAT THE "LEAD HAPTIC UNFOLDED INFERIORLY AND BROKE THE CAPASULOR BAG".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84277 IPURE B1PC2200 - IPURE 1 PIECE PRELOADED INTRAOCULAR LENS (CLEAR), +22.00D HQL BEAVER-VISITEC INTERNATIONAL, INC. 6CM90FZA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O