BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 23420928 · Received October 29, 2025

    Report

    Report Number
    3012236936-2025-000284
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    August 22, 2005
    Report Date
    October 30, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636064
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION A-3B PATIENT GENDER: MALE. SECTION A-6 PATIENT RACE: UNKNOWN/ASKED INFORMATION WAS NOT PROVIDED. SECTION D-6A DATE IMPLANTED: NOT APPLICABLE AS THE IOL WAS NOT IMPLANTED. SECTION D-6B DATE EXPLANTED: NOT APPLICABLE AS THE IOL WAS NOT IMPLANTED; THEREFORE, NOT EXPLANTED. SECTION H-3 DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED. 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 REPORT WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    DURING IMPLANTATION, THE DCB00 MODEL INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED AND FOUND TO BE PREMATURELY ADVANCED. THERE WAS NO MEDICAL ATTENTION, NO MEDICATION PRESCRIBED (OUTSIDE OF STANDARD CARE), AND NO VITRECTOMY. A NEW LENS WAS OPENED AND USED TO COMPLETE THE PROCEDURE. PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS FULLY RECOVERED. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369445 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636064

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male