BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1644714 · Received March 26, 2010

    Report

    Report Number
    1119421-2010-00362
    Event Type
    Other
    Date Received
    March 26, 2010
    Report Date
    February 24, 2010
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 INFO WAS REQUESTED ON 03/02/2010 AND 03/17/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B) (4): (B) (4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "HAVING VARYING DEGREES OF Y SEPARATION/OFFSET", "HAVING DIFFICULTY SEEING IN LOT LIGHT CONDITIONS" (IMPAIRED, VISION); "SEES SHADOWS ABOVE WORDS" (VISUAL DISTURBANCE); "DRY EYES" (DRY EYES). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFO). A CONSUMER REPORTED THAT APPROX 3 YRS FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES, HE IS HAVING DIFFICULTY SEEING IN LOW LIGHT CONDITIONS AND IS "HAVING VARYING DEGREES OF Y SEPARATION/OFFSET (CAN SEE THE SAME LINE TWICE)". HE STATED THAT HE IS VERY PLEASED WITH HIS VISION AND SEES VERY WELL AT NEAR AND DISTANCE; HOWEVER, IN THE LAST THREE TO FOUR MONTHS, HE NOTICED AN INCREASE IN SHADOWS ABOVE WORDS ON HIS COMPUTER, TV, AND STREET SIGNS. HE WAS TOLD BY HIS OPTOMETRIST THAT HE HAS DRY EYES AND GAVE HIM MEDICATION FOR IT. HIS SURGEON INSERTED TEMPORARY PLUGS AND ALSO PRESCRIBED MEDICATION. THE CONSUMER STATED THAT THESE TREATMENTS OFFERED NO IMPROVEMENTS. IN A FOLLOW-UP WITH HIS SURGEON, THE SURGEON REPORTED THAT A CLEAR LENS EXTRACTION WAS PERFORMED ON THIS PT IN 2006 WITH GOOD RESULTS. THE SURGEON BELIEVES THE PT'S SYMPTOMS ARE DUE TO THE PT'S DRY EYES AND THE FACT THAT ALL IOLS DECREASE CONTRAST SENSITIVITY; THE SURGEON IS NOT BLAMING THE LENS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT; THIS REPORT IS FOR THE FELLOW EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN60D3 980718

    Patients

    Seq Age Sex Outcome Treatment
    1 Other