BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ PANOPTIX UV ABSORBING TRIFOCAL IOL

    MDR report key: 16843719 · Received May 1, 2023

    Report

    Report Number
    1119421-2023-00806
    Event Type
    Injury
    Date Received
    May 1, 2023
    Report Date
    May 1, 2023
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    UDI-DI
    00380652429665
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 · 0

    A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED AURA, GLARE, HALOS AND BLURRY VISION. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS HIGHER ORDER ABERRATIONS. ADDITIONAL INFORMATION WAS RECEIVED STATING LENS MAY HAVE ALSO CAUSED SEVERAL BLURRED VISION ALONG WITH OPTIC NEUROPATHY. PATIENT'S SYMPTOMS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1274988 ACRYSOF IQ PANOPTIX UV ABSORBING TRIFOCAL IOL LENS, MULTIFOCAL MFK ALCON RESEARCH, LLC - HUNTINGTON TFAT00 15347014 00380652429665

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Other| R