BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTEC HD

    MDR report key: 10106462 · Received June 1, 2020

    Report

    Report Number
    9613160-2020-00052
    Event Type
    Injury
    Date Received
    June 1, 2020
    Date of Event
    May 8, 2017
    Report Date
    May 29, 2020
    Manufacturer
    LENSTEC BARBADOS INC.
    Product Code
    HQL
    UDI-DI
    00844369027212
    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 30X MAGNIFICATION. BOTH HAPTICS WERE MISSING. THE RETURNED PIECE (OPTIC) OF THE LENS APPEARED SMOOTH ON THE BROKEN CROSS SECTION AREA. THIS SUGGESTS THAT THE HAPTIC BROKE WHILST IN A DEHYDRATED STATE. NO FOREIGN MATERIAL OR DEFECTS WERE SEEN ON THE LENS. THE CARTRIDGE AND LENS ARE COMPATIBLE FOR IMPLANTATION. LENSTEC CAN CONFIRM THAT ALL PROCEDURES IN THE MANUFACTURING AND PACKAGING OF THE LENS WAS CONDUCTED CORRECTLY. THE LENS APPEARED TO BE HANDLED WHILST IN A DEHYDRATED STATE AND THIS CAUSED THE BREAK AT THE HAPTIC.

    Description of Event or Problem · 1

    LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "THE DEVICE WAS BEING RETURNED AS IT WAS EXPLANTED BECAUSE OF A HAPTIC TEAR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570082 SOFTEC HD INTRAOCULAR LENS HQL LENSTEC BARBADOS INC. SOFTECHD+18.0 165073 00844369027212

    Patients

    Seq Age Sex Outcome Treatment
    1