BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1352231 · Received March 27, 2009

    Report

    Report Number
    1119421-2009-00283
    Event Type
    Other
    Date Received
    March 27, 2009
    Date of Event
    February 19, 2009
    Report Date
    February 25, 2009
    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
    WA, 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 INFORMATION WAS REQUESTED ON 02/26/2009, 03/12/2009, 03/13/2009, AND 03/17/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 03/17/2009. THIS REPORT WAS MAILED TO FDA ON: 03/27/2009.

    Description of Event or Problem · 1

    A CONSUMER REPORTED SEEING BRIGHT RADIATING GLARE WHEN DRIVING AT NIGHT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. INFORMATION FROM THE SURGEON REVEALED THAT THE PATIENT HAD POSTERIOR CAPSULE OPACIFICATION. THE SURGEON NOTED THAT THE PATIENT WAS NOW OUT OF TOWN AND WOULD NOT BE SEEN IN FOLLOW UP FOR SOME TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WF 10775059

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other VISCOELASTIC