BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1243132 · Received November 21, 2008

    Report

    Report Number
    1119421-2008-00951
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 27, 2008
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. ADDITIONAL INFORMATION WAS REQUESTED ON 10/29/2008 BY FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 11/04/2008. THIS REPORT WAS MAILED TO FDA ON: 11/21/2008.

    Description of Event or Problem · 1

    AN OFFICE MANAGER REPORTS A PATIENT WHO EXPERIENCED BLURRY NEAR VISION, HALOS, GLARE, PHOTOPSIA FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE LENS WAS EXCHANGED WITH ANOTHER MODEL. IN A FOLLOW-UP, THE SURGEON REPORTS THE PATIENT IS VERY PLEASED WITH THE RESULT POST EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON MA60BM 574639

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention