BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 21044710 · Received December 30, 2024

    Report

    Report Number
    3012236936-2024-000342
    Event Type
    Malfunction
    Date Received
    December 30, 2024
    Date of Event
    December 3, 2024
    Report Date
    December 30, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474728196
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A4, A5: INFORMATION UNKNOWN/NOT PROVIDED. SECTION D6B: IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE LENS REMAINS IMPLANTED. SECTION E1: TELEPHONE NUMBER: (B)(6). SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED; 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 MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON NOTICED THERE WAS A LITTLE PIECE OF PLASTIC THAT CAME OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) INJECTOR AS THE LENS WAS BEING IMPLANTED. THE SURGEON WAS ABLE TO REMOVE THE LITTLE PIECE OF PLASTIC WITH AN INSTRUMENT DURING SURGERY. THERE WAS A FIVE-MINUTE DELAY IN PROCEDURE. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THERE WAS NO MEDICATION PRESCRIBED OUTSIDE STANDARD OF CARE. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088943 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU375 05050474728196

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male