BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 20132651 · Received September 4, 2024

    Report

    Report Number
    3012236936-2024-000240
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    August 27, 2024
    Report Date
    September 3, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731721
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MP, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A3B, GENDER: THE CUSTOMER¿S RESPONSE WAS "MALE". SECTION A5, ETHNICITY: THE CUSTOMER¿S RESPONSE WAS "CHAMORRO". SECTION A6, RACE: THE CUSTOMER¿S RESPONSE WAS "PACIFIC ISLANDER". 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, DEVICE EVALUATED BY MANUFACTURER: 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 PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS SCRATCHED. THE IOL WAS FULLY INSERTED INTO THE EYE. THERE WERE TWO V SHAPED SCRATCHES IN THE CENTRAL OPTIC NOTED AFTER IMPLANTATION. A SECOND INSTRUMENT WAS USED TO REPOSITION THE IOL IN THE ANTERIOR CHAMBER, CUT AND REMOVE IT FROM THE EYE. A NEW IOL OF THE SAME MODEL AND DIOPTER WAS IMPLANTED. THERE WAS NO INJURY TO THE PATIENT OR HIS EYE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055304 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731721

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male