BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL

    MDR report key: 21136160 · Received January 13, 2025

    Report

    Report Number
    1119421-2025-00142
    Event Type
    Injury
    Date Received
    January 13, 2025
    Report Date
    January 13, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MJP
    UDI-DI
    00380652455329
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT VISION WAS INTOLERABLE .THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) MODEL LENS 3 MONTHS 26 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461959 CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON RESEARCH, LLC - HUNTINGTON CCWET3 15346127 00380652455329

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention