BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ PANOPTIX TRIFOCAL IOL

    MDR report key: 17069657 · Received June 6, 2023

    Report

    Report Number
    1119421-2023-01031
    Event Type
    Injury
    Date Received
    June 6, 2023
    Date of Event
    April 13, 2023
    Report Date
    June 6, 2023
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    UDI-DI
    00380652357784
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LENS REMAINS IMPLANTED. 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 CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION IN THE LEFT EYE, THERE WAS GLARE (SIMILAR TO THE SENSATION OF A CONTACT LENS COMING OUT OF THE EYE), HALOS WITH LOTS OF CIRCLES AROUND LIGHTS MAKING IT DIFFICULT TO DRIVE AT NIGHT, FLICKERING (NOT SO OFTEN), BLURRY/HAZY VISION DISRUPTING ALL NEAR/FAR/INTERMEDIATE VISION, PRIMARILY INTERMEDIATE AND FAR, BUT OCCURRED UP CLOSE AS WELL. PERIPHERAL VISION WAS ALSO COMPROMISED IN THE CONSUMER. THE PHYSICAL ACTIVITIES WERE ALSO HINDERED. IT DAMAGED THE CUSTOMER MENTALLY AS WELL; REASONING WAS VERY SLOW COMPARED TO WHAT IT WAS. THE CUSTOMER'S QUALITY OF LIFE SIGNIFICANTLY DECLINED DUE TO INABILITY TO DRIVE, WEAK REFLEXES, AND UNCERTAINTY ABOUT THE DISTANCE, AS WELL AS WORK INSECURITY. THE DOCTOR CONCLUDED FROM THE MEDICAL PROGNOSIS THAT THE LENS WAS IN PLACE AND WITH TIME IT COULD IMPROVE AND THAT THERE WOULD BE NO MORE SHARPNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745234 ACRYSOF IQ PANOPTIX TRIFOCAL IOL LENS, MULTIFOCAL MFK ALCON RESEARCH, LLC - HUNTINGTON TFNT00 15382984 00380652357784

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Other