BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 844753 · Received February 28, 2007

    Report

    Report Number
    1119421-2007-00065
    Event Type
    Other
    Date Received
    February 28, 2007
    Report Date
    January 29, 2007
    Manufacturer
    ALCON LABORATORIES, INC. / HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN REC'D FOR EVAL. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO SIMILAR COMPLAINTS REC'D FOR THIS LOT NUMBER. ADD'L INFO WAS REQUESTED ON 02/01/2007 BY MAIL AND FAX AND ON 01/30/2007, 02/02/2007, 02/16/2007, AND 02/21/2007 BY PHONE.

    Description of Event or Problem · 1

    A CONSUMER REPORTED BLURRED NEAR VISION AND FEELING OFF-BALANCE FOLLOWING UNILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON PROVIDED THE PT WITH A PRESCRIPTION FOR NEAR-SIGHTED VISION CORRECTION AND RECOMMENDED THAT SHE HAVE THE SAME TYPE OF IOL IMPLANTED IN THE FELLOW EYE. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES, INC. / HUNTINGTON SN60D3 934291

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other