BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1235668 · Received November 12, 2008

    Report

    Report Number
    1119421-2008-00892
    Event Type
    Other
    Date Received
    November 12, 2008
    Date of Event
    September 21, 2007
    Report Date
    October 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
    NY, 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 FROM BOTH THE PT'S CURRENT PHYSICIAN AND IMPLANTING SURGEON ON 10/14/2008, 10/20/2008, AND 11/03/2008 BY PHONE, FAX, AND EMAIL. COMPLETED QUESTIONNAIRES WERE RECEIVED ON 10/21/2008 AND 11/03/2008 FROM BOTH SURGEONS. THIS REPORT WAS MAILED TO FDA ON: 11/12/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTS HAVING A PT EXPERIENCING PERSISTENT DYSPHOTOPSIA AND "FLUTTERS" FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. FURTHERMORE, HE STATES THAT THE EYE IS VERY HEALTHY, THERE ARE NO RETINAL PROBLEMS AT THIS TIME; HOWEVER, THE PT HAS HAD A RETINAL TEAR (DATE UNK), AND THAT THE IOL AND SURGERY WERE PERFECT. HE HAS EXPLAINED TO THE PT THAT THESE EVENT HAPPEN FROM TIME TO TIME. THE IMPLANT SURGERY WAS DONE IN 2007, BY ANOTHER SURGEON. IN A FOLLOW-UP, THE IMPLANTING SURGEON REPORTED THAT IN HIS OPINION, 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 10711377

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other