BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTEC HDO

    MDR report key: 10315945 · Received July 23, 2020

    Report

    Report Number
    9613160-2020-00059
    Event Type
    Injury
    Date Received
    July 23, 2020
    Date of Event
    May 20, 2020
    Report Date
    July 23, 2020
    Manufacturer
    LENSTEC BARBADOS INC.
    Product Code
    HQL
    UDI-DI
    00844369037358
    PMA / PMN Number
    P090022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DISCREPANCIES WERE FOUND AS IT RELATES TO THE BATCH DOCUMENTATION ANALYSIS. THE AUDIT DETERMINED THAT ALL PROCEDURES IN THE MANUFACTURING AND PACKAGING OF THE DEVICE HAS BEEN CARRIED OUT CORRECTLY. BATCH RECONCILIATION WAS 100%. THE LENS WAS INSPECTED UNDER A STEREOSCOPIC MICROSCOPE AT 10X MAGNIFICATION. THE VISUAL EXAMINATION CARRIED OUT SHOWED THE LENS WAS FREE FROM ANY TEARS. THE CARTRIDGE AND LENS ARE COMPATIBLE FOR IMPLANTATION.

    Description of Event or Problem · 1

    LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "LENS TORN DURING PROCEDURE. INCISION HAD TO BE MADE BIGGER AND DOC HAD TO USE SUTURE. LIKE LENS IMPLANTED. CART45S CARTRIDGE USED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778815 SOFTEC HDO INTRAOCULAR LENS HQL LENSTEC BARBADOS INC. SOFTECHDO+20.0 F4177 00844369037358

    Patients

    Seq Age Sex Outcome Treatment
    1