BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1744614 · Received June 30, 2010

    Report

    Report Number
    1119421-2010-00760
    Event Type
    Other
    Date Received
    June 30, 2010
    Date of Event
    September 1, 2009
    Report Date
    May 31, 2010
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; DEVICE REMAINS IMPLANTED. 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. THE REPORTER DID NOT PROVIDE ANY CONTACT INFORMATION; THEREFORE, FOLLOW UP WAS NOT ABLE TO BE CONDUCTED. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S) "LIGHT SENSITIVITY, FLASHING, FLICKERING, AURAS, SHADOWS" (VISUAL DISTURBANCES); "HEADACHES" (HEADACHE); "CAT EYE" (NO CODE AVAILABLE); "TEARING" (TEARING, EXCESSIVE). PRODUCT PROBLEMS: "NONE REPORTED" (NO INFORMATION [IOL (INTRAOCULAR LENS) IMPLANT]). A CONSUMER REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE WAS EXPERIENCING LIGHT SENSITIVITY, FLASHING AND CONSTANT FLICKERING WITH AURAS, SHADOWS AND "CAT EYE". THE CONSUMER REPORTED THE GLARE FROM HIS COMPUTER AND OVERHEAD LIGHTS MADE IT IMPOSSIBLE FOR HIM TO WORK WITHOUT A LIGHT SHOW LIKE FIREWORKS WHICH CAUSED HIM HEADACHES. THE REPORTER DID NOT PROVIDE ANY CONTACT INFORMATION; THEREFORE, FOLLOW UP WAS NOT ABLE TO BE CONDUCTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other