BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 4012883 · Received July 21, 2014

    Report

    Report Number
    1119421-2014-00540
    Event Type
    Injury
    Date Received
    July 21, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ALCON RESEARCH, LTD/HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE HAS NOT EEN IDENTIFIED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT AFTER A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT, A PATIENT DID NOT TOLERATE THE COLOUR DIFFERENCE. THE PATIENT REPORTED SHE HAD TO REMOVE HER CARPET SINCE IT SEEMED TOO "NEON YELLOW" AND DESCRIBED OTHER UNSPECIFIC DISTURBANCES WITHOUT INTERRUPTION FOR NEARLY EIGHTEEN MONTHS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425139 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGTON SN6CWS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other