BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 12277986 · Received August 4, 2021

    Report

    Report Number
    9614546-2021-07284
    Event Type
    Injury
    Date Received
    August 4, 2021
    Date of Event
    January 23, 2020
    Report Date
    August 4, 2021
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    POE
    UDI-DI
    05050474579095
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). OTHER: THE DEVICE IS NOT RETURNING FOR EVALUATION AS IT WAS DISCARDED BY THE ACCOUNT; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE/LOT HISTORY RECORD AND COMPLAINT TRENDING 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 · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO VISUAL ISSUES OF GLARES AND HALOS. THE SYMPTOMS WERE NOTICED RIGHT AFTER SURGERY. THE SUSPECT IOL HAS BEEN DISCARDED. THE REPLACEMENT LENS WAS ANOTHER JOHNSON AND JOHNSON IOL OF DIFFERENT MODEL AND DIOPTER. THERE WAS NO OTHER MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT OUTCOME WAS EXCELLENT. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172412 TECNIS IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO MANUFACTURING NETHERLANDS ZXR00 05050474579095

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention