BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 18565440 · Received January 23, 2024

    Report

    Report Number
    3012236936-2024-00173
    Event Type
    Injury
    Date Received
    January 23, 2024
    Date of Event
    November 30, 2023
    Report Date
    January 23, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636095
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTIONS A-2 PATIENT AGE/DATE OF BIRTH, A-4 PATIENT WEIGHT, AND A-5 PATIENT ETHNICITY AND RACE: UNKNOWN/ASKED INFORMATION UNAVAILABLE. SECTION D-6A DATE IMPLANTED: NOT APPLICABLE AS THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. SECTION D-6B DATE EXPLANTED: NOT APPLICABLE AS THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE, THEREFORE NOT EXPLANTED. SECTION H3-81: THE DEVICE WAS NOT 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 REPORT WILL BE FILED. SECTION H6- HEALTH EFFECT - IMPACT CODE: 4625 USED TO CAPTURE VITRECTOMY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DCB00 MODEL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT'S OPERATIVE EYE. THE IOL WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A SULCUS IOL. THERE WAS NO QUALITY ISSUE WITH THE IOL AND NO PATIENT INJURY HOWEVER, VITRECTOMY/MICRO SURGICAL TECHNOLOGY (MST) KIT WAS REQUIRED TO CUT OUT THE IOL. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849192 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636095

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention