BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 22845706 · Received August 19, 2025

    Report

    Report Number
    3012236936-2025-000220
    Event Type
    Malfunction
    Date Received
    August 19, 2025
    Report Date
    September 16, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636057
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, A4, A5 AND A6: UNKNOWN; INFORMATION NOT PROVIDED. SECTION B3: DATE OF EVENT: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. 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 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

    ADDITIONAL INFORMATION: UPON ADDITIONAL INFORMATION RECEIVED, THE DEVICE CODE DC-DELIVERY ISSUE IS NO LONGER APPLICABLE AND THE CODE IS UPDATED TO DC-STUCK IN CARTRIDGE. THEREFORE, THIS FOLLOW-UP #1 IS BEING SUBMITTED TO PROVIDE THE CORRECTED DATA. THERE WILL NO LONGER BE ANY FURTHER REPORTING UNDER MEDWATCH REPORT NUMBER 3012236936-2025-0002204. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS JAMMED. THE CUSTOMER STATED THAT THE LENS WAS IMPLANTED AND EXPLANTED IN SAME PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395190 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636057

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown