BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1914375 · Received November 19, 2010

    Report

    Report Number
    1119421-2010-01281
    Event Type
    Other
    Date Received
    November 19, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 22, 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
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS IMPLANT SURGERY, SHE NOTICED A CONSTANT LINE ON THE TEMPORAL PERIPHERY OF THE LENS. ALSO, SHE REPORTED THAT WHEN SHE LOOKED DOWN, SHE EXPERIENCES A SHAKY SENSATION, AS IF THE LENS WERE SHAKING INSIDE HER EYE. HER SURGEON TOLD HER THAT SHE WILL GET USED TO THE LINE AND THAT THE "SHAKY SENSATION" WOULD IMPROVE WITH TIME. AT THE CONSUMER'S REQUEST, THE SURGEON WAS NOT CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AT3 10966119

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other