BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 12450984 · Received September 9, 2021

    Report

    Report Number
    2020664-2021-07302
    Event Type
    Injury
    Date Received
    September 9, 2021
    Date of Event
    June 4, 2020
    Report Date
    September 9, 2021
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    POE
    UDI-DI
    05050474579040
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT: UNKNOWN, INFORMATION NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS THE LENS 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 · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO MULTIFOCAL LENS INTOLERANCE. THE PATIENT HAD SEVERE GLARE DUE THE PATIENT WAS UNABLE TO DRIVE AT NIGHT. THE PATIENT ALSO HAD BLURRY VISION FOR DISTANCE, NEAR, AND COMPUTER RANGE AND HAD LIGHT SENSITIVITY UNDER ALL LIGHTING CONDITIONS. THE PATIENT NOTICED THE SYMPTOMS RIGHT AFTER THE SURGERY. THE IOL HAS BEEN DISCARDED. ANOTHER COMPETITOR LENS WAS PLACED AS THE REPLACEMENT AND THE PATIENT OUTCOME WAS EXCELLENT. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348321 TECNIS IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO MANUFACTURING NETHERLANDS ZXR00 05050474579040

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention