BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 859602 · Received May 31, 2007

    Report

    Report Number
    1119421-2007-00228
    Event Type
    Other
    Date Received
    May 31, 2007
    Date of Event
    January 1, 2007
    Report Date
    April 30, 2007
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 FOR THIS LOT NUMBER. THIS REPORT WAS MAILED TO THE FDA ON: 05/30/2007. ADDITIONAL INFORMATION WAS REQUESTED ON 05/01/2007, 05/02/2007, 05/15/2007, AND 05/21/2007 BY PHONE, MAIL AND FAX. ADD'L INFO WAS PROVIDED ON 05/01/2007 AND 05/21/2007 BY PHONE AND FAX.

    Description of Event or Problem · 1

    FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A CONSUMER REPORTS MONOCULAR DOUBLE VISION AT NEAR ONLY. THE SURGEON FEELS THIS IS A NEURO ADAPTATION ISSUE. RIGHT EYE MDR #1119421-2007-00228, LEFT EYE MDR #1119421-2007-00229.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES, INC. SN60D3 960701

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other