BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 11556278 · Received March 23, 2021

    Report

    Report Number
    9614546-2021-07104
    Event Type
    Injury
    Date Received
    March 23, 2021
    Report Date
    March 23, 2021
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    POE
    UDI-DI
    05050474605169
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN, BUT THE BEST ESTIMATE IS IN THE MONTH OF FEBRUARY 2021. IF EXPLANTED; GIVE DATE: N/A. LENS REMAINS IMPLANTED. TELEPHONE NUMBER: (B)(6). THE DEVICE IS NOT RETURNING FOR EVALUATION AS IT REMAINS IMPLANTED; THEREFORE, 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 AFTER THE IMPLANTATION OF A TECNIS SYMFONY INTRAOCULAR LENS (IOL), THE PATIENT COMPLAINED THAT THE LENS IS NOT PROVIDING CLEAR VISION AT DISTANCE OR NEAR. THE PATIENT DID HAVE POSTERIOR CAPSULE OPACIFICATION (PCO) THAT THE SURGEON THOUGHT WAS CAUSING THE BLURRINESS. HOWEVER, THERE WAS NO IMPROVEMENT TO THE VISION AFTER YTTRIUM ALUMINUM GARNET (YAG) LASER TREATMENT COMPLETED. VISUAL ACUITY (VA) FOR THE LEFT EYE (OS) PRE-OP WAS 20/30 AND POST-OP IS 20/40. NEAR VISION IS 20/20 FOR BOTH EYES (OU). LENS REMAINS IMPLANTED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447117 TECNIS IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO MANUFACTURING NETHERLANDS ZXT150 05050474605169

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention