BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1180510 · Received September 26, 2008

    Report

    Report Number
    1119421-2008-00755
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    April 1, 2008
    Report Date
    August 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
    CA, US
    Reporter Occupation
    UNKNOWN

    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. ADD'L INFO WAS REQUESTED ON 08/28/2008 AND 08/29/2008 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 09/03/2008.

    Description of Event or Problem · 1

    A CONSUMER REPORTS HAVING BLURRED VISION AND SEEING GRAY SHADOWS AROUND OBJECTS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. SHE HAS BEEN EXAMINED BY A SECOND OPHTHALMOLOGIST AND A RETINAL SPECIALIST, WHO STATE THAT "EVERYTHING LOOKS NORMAL" AND ADVISED HER TO GIVE HER VISION MORE TIME TO ADJUST. A YAG WAS PERFORMED AND SHE WAS GIVEN A PRESCRIPTION FOR GLASSES. HER VISION IS NOW "BRIGHTER", BUT NOT IMPROVED. IN A FOLLOW-UP, IN SURGEON'S OPINION, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGTON SN60AT 10756578

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention