BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 20478232 · Received October 18, 2024

    Report

    Report Number
    3012236936-2024-000280
    Event Type
    Malfunction
    Date Received
    October 18, 2024
    Date of Event
    October 3, 2024
    Report Date
    November 1, 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
    LA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW OF THIS EVENT, IT WAS DETERMINED THAT THE EVENT IS NOT REPORTABLE BECAUSE THERE IS NO ALLEGATION AGAINST THE JOHNSON AND JOHNSON PRODUCT. THE SURGEON EJECTED THE IOL TOO EARLY AND SAID IT WAS USE ERROR. THEREFORE, WE ARE UPDATING THE REPORTED EVENT FROM REPORTABLE TO NOT REPORTABLE. NO FURTHER INFORMATION WILL BE PROVIDED UNDER MANUFACTURER REPORT NUMBER 3012236936-2024-0002801. PLEASE NOTE THAT THE INFORMATION REPORTED IN SECTIONS D2 (COMMON DEVICE NAME), H.6 (HEALTH EFFECT -CLINICAL CODE AND MEDICAL DEVICE PROBLEM CODE) AND SECTION G.1 (MANUFACTURER CONTACT E-MAIL) IS INFORMATION THAT REMAINS UNCHANGED FROM THE INITIAL EMDR REPORT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A3A, A3B, A4, A5, A6, PATIENT INFORMATION: UNKNOWN/NOT PROVIDED. SECTION D6A, IF IMPLANTED, GIVE DATE: NOT APPLICABLE. THERE IS NO INDICATION THE LENS WAS IMPLANTED. SECTION D6B, IF EXPLANTED, GIVE DATE: NOT APPLICABLE. THERE IS NO INDICATION THE LENS WAS IMPLANTED. 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) INADVERTENTLY EJECTED TOO EARLY. THE IOL TOUCHED THE EYE BUT WAS NOT IMPLANTED. THE CUSTOMER SPECIFIED THIS IS A ¿USER ERROR¿. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER IOL OF THE SAME MODEL. THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2207842 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown