BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 15695635 · Received October 29, 2022

    Report

    Report Number
    3012236936-2022-02682
    Event Type
    Malfunction
    Date Received
    October 29, 2022
    Date of Event
    October 4, 2022
    Report Date
    October 28, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636101
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE LENS REMAINS IMPLANTED. DEVICE EVALUATED BY MFR: OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT 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, 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 A FIBER WAS NOTICED ON THE INTRAOCULAR LENS (IOL) AFTER FULL INSERTION AND UNFOLDING. THE FIBER WAS REMOVED FROM PATIENT'S RIGHT EYE AND THE IOL REMAINS IMPLANTED. THERE WERE NO ADDITIONAL SURGICAL INTERVENTIONS REQUIRED AND PATIENT WAS REPORTED TO BE FINE. THE PATIENT WAS EXPERIENCING BLURRY VISION AFTER SURGERY THAT IS STARTING TO RESOLVE ONE WEEK POST-OPERATION. THERE WAS NO REPORTED PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2854490 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636101

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female