BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 853373 · Received May 16, 2007

    Report

    Report Number
    1119421-2007-00203
    Event Type
    Other
    Date Received
    May 16, 2007
    Date of Event
    January 1, 2007
    Report Date
    April 16, 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
    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#. THIS REPORT WAS MAILED TO THE FDA ON: 05/16/2007. ADD'L INFO WAS REQUESTED 04/17/2007 AND 04/25/2007 BY PHONE, FAX AND MAIL. ADD'L INFO WAS PROVIDED 05/08/2007 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A CONSUMER REPORTED BLURRY VISION AND DOUBLE VISION. RIGHT EYE -- OD-- MDR# 1119421-2007-00203. LEFT EYE -- OS -- MDR# 1119421-2007-00204

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES, INC./HUNTINGTON SN60D3 976630

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Other