BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 20872762 · Received December 6, 2024

    Report

    Report Number
    3012236936-2024-000325
    Event Type
    Injury
    Date Received
    December 6, 2024
    Report Date
    December 6, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    POE
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A4, A5, A6: UNKNOWN/ NOT PROVIDED. (B)(6). SECTION H3- NO: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. THERE WAS NO MODEL OR SERIAL NUMBER REPORTED FOR THIS DEVICE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. 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 IMPLANTED IN THE OPERATIVE EYE. THE PATIENT WAS UNHAPPY WITH HIS VISUAL RESULT AND SURGEON EXCHANGED THE IOL FOR JOHNSON & JOHNSON TORIC IOL, BECAUSE THE SURGERY WAS DONE AT TWO DIFFERENT CENTERS THE PATIENT PAID TWICE FOR SPECIALTY LENSES. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2489210 TECNIS IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO MANUFACTURING NETHERLANDS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention