BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1182399 · Received September 12, 2008

    Report

    Report Number
    1119421-2008-00704
    Event Type
    Other
    Date Received
    September 12, 2008
    Date of Event
    July 1, 2008
    Report Date
    August 13, 2008
    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
    PA, US
    Reporter Occupation
    OTHER

    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. ADDITIONAL INFORMATION WAS REQUESTED VIA PHONE ON 08/13/2008, 08/18/2008 AND 08/28/2008 AND VIA FAX AND MAIL ON 08/14/2008. A COMPLETED QUESTIONNAIRE WAS RECEIVED.

    Description of Event or Problem · 1

    A CONSUMER REPORTED EXPERIENCING HAZY VISION AND STARBURST AROUND LIGHTS FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. HE STATED THE STARBURSTS ARE WORSE AT NIGHT AND READING GLASSES DO NOT SEEM TO HELP WITH THE HAZY VISION OR STARBURSTS. THE SURGEON REPORTED THE IOL IS CENTERED AND LOOKS FINE. HE STATED HE DOES NOT THINK THE LENS IS THE CAUSE OF THE PATIENT'S PROBLEMS. HE REPORTED HE OBSERVED A SLIGHT CRINKLE IN THE PATIENT'S POSTERIOR CHAMBER, WHICH HE CONSIDERS VISUALLY INSIGNIFICANT. THE SURGEON STATED HE TOLD THE PATIENT HIS EYES WERE DRY AND OFFERED HIM DRY EYE TREATMENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WF 10817987

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other