BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 23075009 · Received September 17, 2025

    Report

    Report Number
    3012236936-2025-000247
    Event Type
    Injury
    Date Received
    September 17, 2025
    Date of Event
    August 14, 2025
    Report Date
    September 17, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MFK
    UDI-DI
    05050474652637
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3B, A4, A5 AND A6: UNKNOWN, INFORMATION NOT PROVIDED. SECTION E1: INITIAL REPORTER: EMAIL ADDRESS: UNKNOWN, INFORMATION NOT PROVIDED. SECTION E1: INITIAL REPORTER: TELEPHONE NUMBER:(B)(6). SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY FOR PRODUCTION ORDER 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 THE PATIENT EXPERIENCED BLURRED VISION AFTER THE IMPLANTATION OF THE NON-PRELOADED MULTIFOCAL LENS. HOWEVER, BASED ON THE SURGEON'S JUDGMENT, AN EXCHANGE WAS PERFORMED DURING SECONDARY SURGERY USING THE SAME LENS MODEL AND THE SAME DIOPTER. FOLLOWING THE EXCHANGE, THE PATIENT REPORTED CLEAR VISION AND EXPRESSED SATISFACTION WITH THE OUTCOME. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2598381 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO PUERTO RICO MFG. INC. ZFR00V 05050474652637

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention