BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 22015038 · Received May 13, 2025

    Report

    Report Number
    3012236936-2025-000137
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    March 11, 2025
    Report Date
    May 13, 2025
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474810693
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION E1: REPORTER: MIDDLE NAME: UNKNOWN/ NOT PROVIDED SECTION E1: REPORTER: ADDRESS: ADDRESS - LINE 2: UNKNOWN/ NOT PROVIDED SECTION E1: REPORTER: CITY: UNKNOWN/ NOT PROVIDED SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF RECORDS INCLUDING DEVICE HISTORY AND COMPLAINT TRENDING 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 AFTER IMPLANTATION OF ODYSSEY INTRAOCULAR LENS (IOL), PATIENT COMPLAINED OF NO VISION IMPROVEMENT. PATIENT STRUGGLED TO READ STREET SIGNS AND TO READ ON TABLET. IOL WAS EXPLANTED IN SECONDARY PROCEDURE AND ANOTHER LENS OF SAME MODEL WAS IMPLANTED. PRE OPERATIVE BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) WAS 20/20-1 AND POST OPERATIVE BSCVA WAS 20/20. NO UNPLANNED INCISION ENLARGEMENT AND UNPLANNED SUTURES REQUIRED. NO UNPLANNED VITRECTOMY WAS REQUIRED. THERE WAS NO DELAY IN PROCEDURE. NO MEDICATIONS WERE PRESCRIBED. PATIENT WAS FULLY RECOVERED. NO FURTHER INFROMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182951 TECNIS SIMPLICITY LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRN00V 05050474810693

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention