BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ VIVITY TORIC EXTENDED VISION UV ABSORBING IOL

    MDR report key: 12712355 · Received October 28, 2021

    Report

    Report Number
    1119421-2021-02015
    Event Type
    Injury
    Date Received
    October 28, 2021
    Date of Event
    August 20, 2021
    Report Date
    October 28, 2021
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    POE
    UDI-DI
    00380652427159
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE DEVICE 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. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT, FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT HAD EXPERIENCED AN UNEXPECTED OUTCOME DUE TO IRREGULAR ASTIGMATISM AND LARGE HIGH ORDER ABERRATIONS (HOAS) FROM PREVIOUS RADIAL KERATOTOMY (RK). THE ABERRATION FROM RK IS INTERFERING WITH CENTRAL BUTTON ON THE IOL AND DECREASING QUALITY OF VISION. ADDITIONAL INFORMATION WAS PROVIDED BY A SURGICAL COORDINATOR, THAT THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL IOL IN A SECONDARY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1611356 ACRYSOF IQ VIVITY TORIC EXTENDED VISION UV ABSORBING IOL INTRAOCULAR LENS POE ALCON RESEARCH, LLC - HUNTINGTON DAT315 15062407 00380652427159

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention MONARCH III IOL CARTRIDGE C| MONARCH III IOL INJECTOR| PROVISC