BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 20688631 · Received November 14, 2024

    Report

    Report Number
    3012236936-2024-000306
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    October 23, 2024
    Report Date
    November 14, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636040
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION A-3B PATIENT GENDER: FEMALE WAS THE ANSWER PROVIDED. SECTION A-4 PATIENT WEIGHT: : UNKNOWN/ASKED INFORMATION WAS NOT PROVIDED. SECTION D-6B DATE EXPLANTED: NOT APPLICABLE AS THE IOL REMAINS IMPLANTED; THEREFORE, NOT EXPLANTED. SECTION H-3 DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). 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 REPORT WILL BE FILED. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION REGARDING COMPLAINT HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    SEVERAL LINEAR FIBERS WERE NOTED WITHIN THE PRE-LOADED DCB00 MODEL CARTRIDGE AND WERE INJECTED INTO THE ANTERIOR CHAMBER ALONG WITH THE INTRAOCULAR LENS (IOL). THE DOCTOR WAS ABLE TO RETRIEVE THE FIBERS USING A 27 GAUGE CANNULA. THE FOLLOWING ARE ALL UNKNOWNS: DAILY ACTIVITIES SIGNIFICANTLY AFFECTED, INCISION ENLARGEMENT, SUTURE(S), VITRECTOMY, MEDICATION PRESCRIBED (OUTSIDE OF STANDARD CARE), IF MEDICAL ATTENTION WAS REQUIRED, AND PATIENT STATUS POST PROCEDURE. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2217451 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636040

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female