BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 24298438 · Received February 9, 2026

    Report

    Report Number
    3012236936-2026-000024
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    January 15, 2026
    Report Date
    February 9, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474825352
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D6B: IF EXPLANTED; GIVE DATE: NOT APPLICABLE AS LENS WAS NOT EXPLANTED. SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY FOR PRODUCTION ORDER FOR THIS DEVICE 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 THERE WAS A CRACK ON THE INTRAOCULAR LENS (IOL) OPTIC AFTER FULL IMPLANTATION. THE CRACKED IOL COULD NOT BE REMOVED AND REMAINS IN THE PATIENT¿S EYE. THERE WAS NO INJURY. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. PATIENT POSTOP OUTCOME WAS GOOD. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359764 TECNIS SIMPLICITY LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRN00V 05050474825352

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown