BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 884001 · Received July 20, 2007

    Report

    Report Number
    1119421-2007-00308
    Event Type
    Other
    Date Received
    July 20, 2007
    Date of Event
    January 1, 2007
    Report Date
    June 21, 2007
    Manufacturer
    ALCON LABORATORIES, INC /HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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 NUMBER. THIS REPORT WAS MAILED TO THE FDA ON: 07/20/2007. ADDITIONAL INFORMATION WAS REQUESTED 06/2/2007, 07/03/2007 AND 07/13/2007 BY PHONE, MAIL AND FAX. ADDITIONAL INFORMATION WAS RECEIVED 07/11/2007 AND 07/13/2007 BY FAX AND PHONE.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A THIN FILM IS NOTED OVER BOTH LENSES. THE SURGEON FEELS THIS IS AFFECTING THE PT'S VISUAL ACUITY AND MAY BE AN ALLERGIC REACTION TO THE LENS MATERIAL. RIGHT EYE: MDR #1119421-2007-00307, LEFT EYE: MDR #1119421-2007-00308.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES, INC /HUNTINGTON SA60AT 947331

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other