BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1022967 · Received March 28, 2008

    Report

    Report Number
    1119421-2008-00194
    Event Type
    Other
    Date Received
    March 28, 2008
    Date of Event
    January 1, 2008
    Report Date
    February 27, 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
    OR, US
    Reporter Occupation
    UNKNOWN

    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 02/28/2008, 03/04/2008 AND 03/07/2008 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS REC'D.

    Description of Event or Problem · 1

    A CONSUMER REPORTS HAVING DOUBLE VISION, GHOSTING AND POOR DISTANCE VISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A FOLLOW-UP, THE SURGEON REPORTS THE PROGNOSIS AS "GOOD" AND REPORTS THAT SHE DOES NOT BELIEVE THE SYMPTOMS ARE RELATED TO A LENS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGTON SN60WF 10759870

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other