BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 929983 · Received October 18, 2007

    Report

    Report Number
    1119421-2007-00419
    Event Type
    Other
    Date Received
    October 18, 2007
    Date of Event
    January 1, 2007
    Report Date
    September 18, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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: 10/18/2007. ADDITIONAL INFORMATION WAS REQUESTED 09/20/2007 AND 09/24/2007 BY PHONE, FAX AND MAIL. ADDITIONAL INFORMATION WAS RECEIVED 09/20/2007, 09/27/2007 AND 09/28/2007 BY PHONE AND FAX.

    Description of Event or Problem · 1

    A SURGEON REPORTS, AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) SURGERY. THE PT REPORTED SEEING AN "ARC OR WHEEL" SINCE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES, INC/ HUNTINGTON SN6AD3 10725248

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other ANTI-INFLAMMATORY| ANTIBIOTIC