BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 16091661 · Received January 3, 2023

    Report

    Report Number
    3012236936-2023-00005
    Event Type
    Injury
    Date Received
    January 3, 2023
    Report Date
    January 3, 2023
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474652637
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION UNKNOWN/ NOT PROVIDED. PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS REMAINS IMPLANTED. TELEPHONE NUMBER: (B)(6). THE DEVICE WAS NOT RETURNED FOR EVALUATION AS THE LENS REMAINS IMPLANTED IN THE EYE. 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 DURING THE EXAMINATION THE PATIENT SAID THAT HE IS NOT HAPPY WITH FAR DISTANCE VISION AFTER THE SURGERY, AND AS TIME GOES BY THE SITUATION IS GETTING WORSE. IN ADDITION, HE CANNOT HAVE A CLEAR VISION WITH GLASSES NEITHER AND HIS DAILY ACTIVITIES ARE SIGNIFICANTLY AFFECTED. THROUGH FOLLOW-UP WE LEARNED THAT ZFR00V INTRAOCULAR LENSES (IOL) WERE USED, AND THAT THEY REMAIN IMPLANTED. THE OD (RIGHT EYE) SN (B)(4), DATE OF SURGERY (B)(6) 2021; OS (LEFT EYE) SN (B)(4) DATE OF SURGERY (B)(6) 2021. THE PATIENT'S VISUAL ACUITY PRIOR TO THE IMPLANTATION OF THE ORIGINAL LENS WAS OD CORRECTED DISTANCE VISUAL ACUITY(CDVA): 0.9 AND OS CDVA: 1.0 AND THE VISUAL ACUITY AFTER THE IMPLANTATION OF THE ORIGINAL IOL MEASURED AT OD CDVA: 0.8 AND OS CDVA: 0.7. YTTRIUM ALUMINUM GARNET (YAG) LASER CAPSULOTOMY DONE TO BOTH EYES (OU) ON (B)(6) 2022. THE PATIENT IS NOT SATISFIED WITH DISTANCE VISION; LAST POST-OPERATIVE VISIT WAS DONE ON SEPTEMBER 24, 2022. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE LENS IMPLANTED IN THE RIGHT EYE, SN (B)(4). A REPORT IS BEING SUBMITTED FOR THE LENS IMPLANTED IN THE LEFT EYE, SN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131977 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS ZFR00V 05050474652637

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention