BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 17982146 · Received October 21, 2023

    Report

    Report Number
    3012236936-2023-02681
    Event Type
    Injury
    Date Received
    October 21, 2023
    Date of Event
    August 25, 2022
    Report Date
    March 15, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MFK
    UDI-DI
    05050474750654
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION. SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: DATE RETURNED TO MANUFACTURER: (B)(6) 2024. SECTION H3: EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE LENS WAS RECEIVED. THE LENS WAS VISUALLY INSPECTED UNDER MAGNIFICATION REVEALING THAT THE LENS WAS CUT IN HALF AND COATED IN VISCOELASTIC RESIDUE. THE LENS WAS CLEANED AND INSPECTED, AND NO ISSUES WITH THE LENS THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUE WERE IDENTIFIED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION H3-OTHER (81): 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER INSERTING THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED BLURRINESS ON PERIPHERAL WITH LACK OF FOCUS. THE IOL WAS EXPLANTED AND REPLACED WITH A NON-JNJ LENS (ALCON VIVITY LENS). THE PATIENT WAS NOT INJURED AND THERE WERE NO COMPLICATIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY, SUTURES, OR PRESCRIBED MEDICATION. THE PATIENT¿S OUTCOME IS VERY CLEAR VISION AND THEY¿RE HAPPY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1996097 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO PUERTO RICO MFG. INC. DFR00V 05050474750654

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention