BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 18070437 · Received November 4, 2023

    Report

    Report Number
    3012236936-2023-02788
    Event Type
    Malfunction
    Date Received
    November 4, 2023
    Date of Event
    October 25, 2023
    Report Date
    November 3, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731837
    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

    SECTION D6A, IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. SECTION D6B, IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. THEREFORE, NOT EXPLANTED. SECTION H3-OTHER (81): THE DEVICE HAS NOT BEEN 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE, IT HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) HAD A LENS DEFECT IN THE OPTIC. THE IOL WAS INSERTED AND THEN REMOVED. THE PROCEDURE WAS COMPLETED WITH A BACKUP LENS OF THE SAME MODEL AND DIOPTER. THERE WERE NO OTHER COMPLICATIONS SUCH AS A CAPSULE TEAR, UNPLANNED VITRECTOMY, OR SUTURES. CUSTOMER INDICATED FOR THE CARTRIDGE LUBRICATION THEY USED ALCON BALANCE SALT SOLUTION (BSS) AT ROOM TEMPERATURE AND NO ADDITIVES. CUSTOMER REPORTED THE CERTIFIED OPHTHALMIC ASSISTANT (COA) PERFORMS THE INITIAL MOVEMENT OF THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1952143 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731837

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male