BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 16702678 · Received April 7, 2023

    Report

    Report Number
    3012236936-2023-00837
    Event Type
    Malfunction
    Date Received
    April 7, 2023
    Date of Event
    March 16, 2023
    Report Date
    April 7, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474635951
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTIONS A-5 PATIENT ETHNICITY AND RACE: UNKNOWN/ASKED INFORMATION UNAVAILABLE. SECTION D-6A DATE IMPLANTED: NOT APPLICABLE, AS THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. SECTION D-6B DATE EXPLANTED: NOT APPLICABLE, AS THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE, THEREFORE NOT EXPLANTED. SECTION H3-81: THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED. 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. SECTION H-6 HEALTH EFFECT - IMPACT CODE: 4631 IOL REMOVAL AND REPLACEMENT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN INSERTING THE PRE-LOADED DCB00 INTRAOCULAR LENS (IOL) INTO THE PATIENT'S OPERATIVE EYE THE DOCTOR SAW A DIVOT ON THE OPTIC. LENS WAS CUT IN HALF WITH MICROSURGICAL TECHNOLOGY (MSTS) AND REMOVED WITH UTROTTAS AND ANOTHER LENS WITH THE SAME MODEL AND DIOPTER WAS IMPLANTED. THERE WAS NO PATIENT INJURY. DOCTOR STATED THIS LOOKS FINE. 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
    440530 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474635951

    Patients

    Seq Age Sex Outcome Treatment
    1 Female