BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 22687372 · Received August 1, 2025

    Report

    Report Number
    3012236936-2025-000208
    Event Type
    Malfunction
    Date Received
    August 1, 2025
    Date of Event
    July 1, 2025
    Report Date
    August 1, 2025
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474810631
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A3B AND A4 : UNKNOWN/INFORMATION NOT PROVIDED. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, REMAINS IMPLANTED IN THE EYE. SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF RECORDS INCLUDING DEVICE HISTORY AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRELOADED INTRAOCULAR LENS INSERTION, INITIAL ADVANCEMENT WAS DIFFICULT AND REQUIRED SLIGHTLY MORE FORCE THAN USUAL TO START, BUT IT BECAME EASIER ONCE THE LENS PROGRESSED THROUGH THE INSERTER. THERE WAS SOME DIFFICULTY DELIVERING THE LENS INTO THE EYE DUE TO A TIGHT THREAD MECHANISM. AFTER IMPLANTATION AND ASPIRATION/IRRIGATION TO REMOVE RESIDUAL CORTEX, A MARK ON THE LENS WAS OBSERVED ON THE RIGHT, WHICH WAS INITIALLY MISTAKEN FOR RESIDUAL CORTEX. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED, EXCEPT FOR THE POTENTIAL NEED FOR YAG (YTTRIUM ALUMINUM GARNET) LASER POSTERIOR CAPSULOTOMY IN THE FUTURE. THE PATIENT HAS THE IMPLANT IN THE EYE, WITH NO COMPLAINTS, AND IS DOING VERY WELL POST-OPERATIVELY. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2278636 TECNIS SIMPLICITY LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRN00V 05050474810631

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male