BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1709330 · Received June 2, 2010

    Report

    Report Number
    1119421-2010-00653
    Event Type
    Other
    Date Received
    June 2, 2010
    Date of Event
    January 1, 2010
    Report Date
    May 3, 2010
    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
    NJ, 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 ON 05/13/2010 AND 05/20/2010 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): "SEEING A LINE IN VISION" (VISION, IMPAIRED). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFORMATION). A SURGEON REPORTED A PATIENT SEEING A LINE IN VISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON HAS REFERRED THE PATIENT TO ANOTHER SURGEON. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 10970070

    Patients

    Seq Age Sex Outcome Treatment
    1 Other