BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ PANOPTIX TRIFOCAL IOL

    MDR report key: 15303399 · Received August 26, 2022

    Report

    Report Number
    1119421-2022-01860
    Event Type
    Malfunction
    Date Received
    August 26, 2022
    Date of Event
    July 12, 2022
    Report Date
    August 26, 2022
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED STRONG GLISTENING WAS OBSERVED AND VISUAL ACUITY DECREASED. THE REPORTER STRONGLY BELIEVED THAT THE CAUSE WAS THE GLISTENING BECAUSE THERE WERE NO OTHER ABNORMALITIES IN THE EYEGROUND ETC. AT THIS TIME, THE PATIENT IS UNDER FOLLOW-UP WITHOUT ANY SPECIAL TREATMENT. THE SAMPLE IS NOT AVAILABLE AS IT STILL REMAINS IN THE PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1773166 ACRYSOF IQ PANOPTIX TRIFOCAL IOL LENS, MULTIFOCAL MFK ALCON RESEARCH, LLC - HUNTINGTON TFNT00 12737890

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown