BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ PANOPTIX UV ABSORBING TRIFOCAL IOL

    MDR report key: 15864655 · Received November 25, 2022

    Report

    Report Number
    1119421-2022-02476
    Event Type
    Injury
    Date Received
    November 25, 2022
    Report Date
    November 25, 2022
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    UDI-DI
    00380652429719
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED STARBURST, AND HALOS AROUND LIGHTS. CONSUMER'S DOCTOR DID A LENS EXCHANGE IN BOTH EYES WITH THE COMPANY LENS. DOCTOR DID DO A LASER TREATMENT TO TRY TO HELP BUT IT MADE IT WORSE BOTH EYES. CONSUMER CAN'T DRIVE AT NIGHT BECAUSE OF THE ONCOMING LIGHTS AND ALL THE STARBURSTS AND HALOS, EVERYTHING IS DISTORTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED THAT THE SYMPTOMS STARTED IMMEDIATELY AFTER SURGERY. HAS SEEN RETINAL SPECIALIST AND FINDINGS WERE NORMAL. USING SPECIAL SUN GLASSES TO FUNCTION INDOORS. HAS LEFT HIS JOB BECAUSE OF DEBILITATING GLARE AND IMPACT ON DAILY LIVING ACTIVITIES. HAS SEEN DIFFERENT SECOND OPINION SURGEONS. HAS BEEN ON VUITY DROPS WITH NO IMPROVEMENT OVER TIME. DOES NOT RECOMMEND IOL EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2733014 ACRYSOF IQ PANOPTIX UV ABSORBING TRIFOCAL IOL LENS, MULTIFOCAL MFK ALCON RESEARCH, LLC - HUNTINGTON TFAT00 15031942 00380652429719

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention| O