BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 19627483 · Received June 27, 2024

    Report

    Report Number
    3012236936-2024-000167
    Event Type
    Malfunction
    Date Received
    June 27, 2024
    Report Date
    July 17, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474655461
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    TELEPHONE NUMBER: (B)(6). SECTION THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT 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 AND POSSIBLE PRODUCT RETURN AND EVALUATION, 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, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    NEW INFORMATION AND CORRECTED DATA: ACCOUNT CLARIFIED THAT THE LENS DID NOT CAUSE ANY PROBLEMS TO THE PATIENT. THE SUSPECT PRODUCT WAS CONTAMINATED OR DAMAGED DURING OPENING OF THE PACKAGING, AND THERE IS NO PROBLEM RELATED TO THE QUALITY OF THE PRODUCT. NO DEFICIENCY WAS BEING REPORTED. UPON FURTHER REVIEW OF THE NEW INFORMATION RECEIVED IT WAS DETERMINED THAT THE REPORTED INCIDENT DOES NOT CONSTITUTE A MALFUNCTION. THEREFORE, THE EVENT IS NO LONGER CONSIDERED AS REPORTABLE AND NO FURTHER REPORTS WILL BE SUBMITTED UNDER REPORT NUMBER 3012236936-2024-0001674. 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 INTRAOCULAR LENS (IOL) WAS DAMAGED. NO ADDITIONAL INFORMATION WAS RECEIVED. THIS ISSUE OCCURRED WITH TWO INDIVIDUAL LENSES. A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER LENS. THIS IS REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2185139 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474655461

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose