BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 13642380 · Received March 1, 2022

    Report

    Report Number
    3012236936-2022-00537
    Event Type
    Injury
    Date Received
    March 1, 2022
    Date of Event
    January 27, 2022
    Report Date
    March 1, 2022
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474751873
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE OR DATE OF BIRTH, WEIGHT, AND ETHNICITY: UNKNOWN / NOT PROVIDED AS ACCOUNT PROVIDED THAT NO FURTHER INFORMATION IS AVAILABLE. THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS IT WAS DISCARDED. 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 & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE AND THEN EXPLANTED MONTHS LATER DUE TO THE PATIENT EXPERIENCING VERY BOTHERSOME HALOS AND GLARE WHEN DRIVING AT NIGHT, WHICH SEEMED WORSE AROUND RED LIGHTS. THE PATIENT REQUESTED TO HAVE THE IOL REMOVED. THE PROCEDURE WAS COMPLETED USING A COMPETITOR IOL (MODEL: LIGHT ADJUSTABLE). THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH THE PATIENT'S ACTIVITIES OF DAILY LIFE. THE CURRENT PATIENT STATUS IS UNKNOWN. THE EXPLANTED IOL WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2226519 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DFW225 05050474751873

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention