BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 16748217 · Received April 14, 2023

    Report

    Report Number
    3012236936-2023-00900
    Event Type
    Injury
    Date Received
    April 14, 2023
    Report Date
    June 6, 2023
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474652637
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW OF THIS EVENT IT WAS DETERMINED THAT THE EVENT IS NOT REPORTABLE. IT IS UNKNOWN IF THE REPORTED EVENT IS DEBILITATING AND UNKNOWN HOW MUCH TIME POST-SURGERY. THEREFORE, WE ARE UPDATING THE REPORTED EVENT FROM REPORTABLE TO NOT REPORTABLE. NO FURTHER INFORMATION WILL BE PROVIDED UNDER MANUFACTURER REPORT NUMBER 3012236936- 2023- 00900. PLEASE NOTE THAT THE INFORMATION REPORTED IN SECTIONS D2 (COMMON DEVICE NAME), H.6 (HEALTH EFFECT -CLINICAL CODE AND MEDICAL DEVICE PROBLEM CODE) AND SECTION G.1 (MANUFACTURER CONTACT E-MAIL) IS INFORMATION THAT REMAINS UNCHANGED FROM THE INITIAL EMDR REPORT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A, PATIENT INFORMATION: A2, A4, A5: INFORMATION UNKNOWN/ASKU. SECTION B3 DATE OF EVENT: UNKNOWN/NOT PROVIDED. SECTION D6A, IF IMPLANTED, GIVE DATE: UNKNOWN/NOT AVAILABLE. SECTION D6B, IF EXPLANTED, GIVE DATE: UNKNOWN/NOT AVAILABLE. SECTION E1, TELEPHONE NUMBER: 571-212-1911. ENTERING THE TELEPHONE NUMBER IN H10 AS THE FIELD ONLY TAKES THE US FORMAT. SECTION H3-OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. 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. AN ATTEMPT WAS MADE TO OBTAIN THE MISSING INFORMATION. REPORTEDLY, THERE IS NO FURTHER INFORMATION AVAILABLE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S LEFT EYE. AFTER THE IMPLANT, THEY BEGAN TO EXPERIENCE DYSPHOTOPSIA, HALOS, AND SENSITIVITY TO LIGHT. THE PATIENT REQUESTED THAT THE IOL BE EXPLANTED DUE TO THE DISCOMFORT RESULTING FROM THE RESULTS OF THE IMPLANT. REPORTEDLY, THE ISSUE IS NOT RELATED TO USE ERROR. AT THE TIME OF THIS REPORT THE IOL WAS NOT EXPLANTED. THE DOCTOR MAY DECIDE TO EXPLANT THE IOL DUE TO THE PATIENT¿S COMPLAINTS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2319594 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS ZFR00V 05050474652637

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown