BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 14028189 · Received April 6, 2022

    Report

    Report Number
    3012236936-2022-00781
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    August 24, 2021
    Report Date
    April 6, 2022
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    HQL
    UDI-DI
    05050474750678
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS IT WAS DISCARDED BY THE CUSTOMER; THEREFORE, FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE 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 · 0

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT (OD) EYE AND REPLACED WITH A NON-JOHNSON AND JOHNSON LENS, LENS FROM BAUSCH AND LOMB MODEL LI61AO WITH 20.5 DIOPTER POWER, IN A SECONDARY PROCEDURE. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION PERFORMED. REPORTEDLY, THE PATIENT IS DOING FINE POST-SURGERY. THE LENS HAS BEEN DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1900180 TECNIS IOL INTRAOCULAR LENS HQL AMO MANUFACTURING NETHERLANDS DFR00V 05050474750678

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention