BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 13006409 · Received December 14, 2021

    Report

    Report Number
    3012236936-2021-00246
    Event Type
    Injury
    Date Received
    December 14, 2021
    Report Date
    December 14, 2021
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474751279
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: EXACT DATE UNKNOWN/ NOT PROVIDED. BEST ESTIMATE DATE IS BETWEEN (B)(6) 2021. THE DEVICE WAS NOT RETURNED FOR ANALYSIS, 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 THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE DUE TO PATIENT COMPLAINING OF WAXY VISION AND COULD NOT TOLERATE THE LACK OF CRISP, CLEAR VISION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895209 TECNIS IOL EXTENDED DEPTH OF FOCUS IOL MFK AMO MANUFACTURING NETHERLANDS DFW150 05050474751279

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention