BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 21048616 · Received December 31, 2024

    Report

    Report Number
    3012236936-2024-000348
    Event Type
    Injury
    Date Received
    December 31, 2024
    Date of Event
    November 26, 2024
    Report Date
    December 31, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474536234
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: PER REGULATION EU (B)(4) (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3 -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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS LEFT WITH A RESIDUAL VISION OF +1.00 AND EXPRESSED CONCERNS ABOUT THE PRE AND POST-OPERATIVE BIOMETRICS, PARTICULARLY DUE TO THE PATIENT'S ENLARGED ANTERIOR CHAMBER. THROUGH FOLLOW-UP WE LEARNED THAT EXPLANT WAS DONE ON 10TH DECEMBER. BEFORE THE EXPLANT THE PATIENT WAS CALM, CARRYING OUT ALL HIS ACTIVITIES NORMALLY, HE WAS JUST UPSET WITH THE RESIDUAL DEGREE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1847436 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS ZMB00 05050474536234

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Other