BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1220573 · Received October 31, 2008

    Report

    Report Number
    1119421-2008-00864
    Event Type
    Other
    Date Received
    October 31, 2008
    Date of Event
    May 20, 2008
    Report Date
    October 3, 2008
    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
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROD WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PROD MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 10/13/2008 BY FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 10/16/2008.

    Description of Event or Problem · 1

    A CONSUMER AND HIS SPOUSE REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE IS HAVING DIFFICULTY SEEING AT NIGHT DUE TO GLARE AND HALOS. IN A F/U, THE SURGEON REPORTED THAT THE PT'S OUTCOME IS PERFECT WITH AN UNCORRECTED VISION OF 20/20. HE HAS REFERRED THE PT FOR A SECOND OPINION THAT CONFIRMED THERE WAS NO PROBLEM WITH THE IOL. FURTHERMORE, THE SURGEON PLANS TO REFER THE PT FOR A THIRD OPINION, AS WELL AS, A PLASTIC SURGEON REGARDING THE PT'S PTOSIS. THERE ARE TWO MEDICAL DEVICE REPORTS FOR THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./ HUNTINGTON SN6AD3 10744140

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other