BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 17463709 · Received August 4, 2023

    Report

    Report Number
    3012236936-2023-01924
    Event Type
    Malfunction
    Date Received
    August 4, 2023
    Date of Event
    July 11, 2023
    Report Date
    August 4, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474655478
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION D6B - EXPLANT DATE: NOT APPLICABLE, AS LENS REMAINS IMPLANTED. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3 - OTHER (81): THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING IMPLANTATION OF THE INTRAOCULAR LENS (IOL), THE SURGEON NOTICED A SLIGHT STIFFNESS WHEN ADVANCING THE LENS. AS HE UNFOLDED THE IOL IN THE CAPSULAR BAG, HE NOTICED A SMALL DAMAGE ON THE EDGE OF THE LENS, IN THE TRANSITION FROM OPTIC TO HAPTIC. HE DECIDED TO LEAVE THE IMPLANT IN THE EYE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952600 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474655478

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown