BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 731148 · Received June 30, 2006

    Report

    Report Number
    1119421-2006-00233
    Event Type
    Other
    Date Received
    June 30, 2006
    Report Date
    June 2, 2006
    Manufacturer
    ALCON LABORATORIES, INC. / HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    H.3.,6: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED FOR THIS LOT NUMBER.

    Description of Event or Problem · 1

    A PATIENT REPORTS THE VISION IN HER LEFT EYE IS MILKY (BLURRED) FOLLOWING INTRAOCULAR LENS IMPLANT SURGERY. SHE HAD CATARACT SURGERY ON HER RIGHT EYE AND HER VISION WAS CLEAR IMMEDIATELY. HER SURGEON STATES HER EXAM WAS NORMAL AND THE EYE WAS 90% HEALED. SHE WAS REFERRED BACK TO HER SURGEON AND ADVISED THAT SHE MAY REQUIRE SOME ADDITIONAL TIME FOR ADJUSTMENT. ADDITIONAL INFORMATION, INCLUDING THE PATIENT'S CURRENT STATUS, HAS BEEN REQUESTED FROM HER IMPLANTING SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES, INC. / HUNTINGTON SA60D3 926551

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other