BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1221634 · Received November 5, 2008

    Report

    Report Number
    1119421-2008-00873
    Event Type
    Other
    Date Received
    November 5, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 6, 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 REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 10/07/2008 AND 10/15/2008 BY FAX, MAIL, AND PHONE. A COMPLETED QUESTIONAIRE WAS RECEIVED ON 10/15/2008.

    Description of Event or Problem · 1

    A CONSUMER AND HER HUSBAND REPORTED THAT SHE SEES SPARKLING LIGHTS (STARBURSTS) INTERMITTENTLY FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. SHE SEES THEM WHEN OUTSIDE AND HAS DIFFICULTY AT NIGHT. SHE FURTHER REPORTED THAT SHE SAW STARBURSTS PRIOR TO SURGERY BUT THEY ARE MORE PRONOUNCED NOW. SHE WAS REFERRED TO A NEURO-OPHTHALMOLOGIST WHO TOLD HER THAT THE "FLICKERING OF THE LIGHT IS NOT RELATED BUT IS SOMETHING VISUAL." IN THE OPINION OF THE SURGEON, THE DEVICE DID NOT CAUSE/CONTRIBUTE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WF 10710206

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other