BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF

    MDR report key: 1031444 · Received April 18, 2008

    Report

    Report Number
    1119421-2008-00254
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    February 5, 2008
    Report Date
    March 19, 2008
    Manufacturer
    ALCON RESEARCH, LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 ARE NO OTHER REPORTS IN THE LOT. ADDITIONAL INFO WAS REQUESTED AND RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT HIS PT COMPLAINED OF VISUAL IMPAIRMENT THREE AND A HALF YEARS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. UPON EXAMINATION, THE SURGEON NOTED PIGMENTED BUTTONS DEPOSITS IN THE IOL (OD). THE SURGEON REPORTED HE BELIEVES THE LOSS OF VISUAL ACUITY (VA) WAS DUE OPTIC NEUROPATHY DUE TO THE PATIENT'S NICOTINISM (+++) AND NOT RELATED TO THE IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. SN60AT 819161

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other