BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 939166 · Received November 6, 2007

    Report

    Report Number
    1119421-2007-00454
    Event Type
    Other
    Date Received
    November 6, 2007
    Date of Event
    January 1, 2007
    Report Date
    October 7, 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
    IA, US
    Reporter Occupation
    OTHER

    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. THIS REPORT WAS MAILED TO THE FDA ON: 11/06/2007. ADDITIONAL INFORMATION WAS REQUESTED 10/17/2007, 10/22/2007 AND 10/23/2007 BY MAIL, FAX AND PHONE. ADDITIONAL INFORMATION WAS RECEIVED 10/19/2007, 10/23/2007 AND 10/25/2007 BY FAX AND PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    A SURGEON REPORTS, THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PATIENT REPORTED HAZINESS AND GHOSTING FOR TEN DAYS. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT: MDR #1119421-2007-00454; MDR #1119421-2007-00455.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES, INC./HUNTINGTON SN6AD3 10731155

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other