BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 846874 · Received May 9, 2007

    Report

    Report Number
    1119421-2007-00180
    Event Type
    Other
    Date Received
    May 9, 2007
    Date of Event
    January 1, 2007
    Report Date
    April 9, 2007
    Manufacturer
    ALCON LABORATORIES, INC./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS IN THIS LOT NUMBER. THIS REPORT WAS MAILED TO THE FDA ON: 05/09/2007. ADDITIONAL INFO WAS REQUESTED 04/10/2007, 04/16/2007, 04/24/2007, AND 05/03/2007 BY PHONE, MAIL AND FAX. ADDITIONAL INFO WAS PROVIDED ON 04/11/2007, 04/17/2007 AND 04/25/2007 BY PHONE AND FAX. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT REPORTED MONOCULAR GHOSTING. ADDITIONAL INFO, INCLUDING THE PT'S STATUS, HAS BEEN REQUESTED. RIGHT EYE: MDR#1119421-2007-00179. LEFT EYE: MDR#1119421-2007-00180.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES, INC./HUNTINGTON SA60D3 893610

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Other