BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 21734155 · Received March 31, 2025

    Report

    Report Number
    3012236936-2025-000081
    Event Type
    Malfunction
    Date Received
    March 31, 2025
    Date of Event
    March 6, 2025
    Report Date
    July 2, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636118
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3B, A4, A5 AND A6: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED. 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, 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.

    Additional Manufacturer Narrative · 0

    UPON REVIEW, THE FILE IS NO LONGER REPORTABLE, AS THIS COMPLAINT (B)(4) (3012236936-2025-0000815) IS A DUPLICATE OF COMPLAINT (B)(4) (3012236936-2025-0000816), WHICH HAS ALREADY BEEN SUBMITTED TO HEALTH AUTHORITY." NO FURTHER INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON OPENED THE PACKAGE AND FOUND A CRACK IN THE CENTER OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS. THE LENS WAS NOT USED FOR IMPLANTATION AND WAS LATER REPLACED WITH ANOTHER LENS OF THE SAME DIOPTER FOR IMPLANTATION. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055222 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636118

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown