BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1975813 · Received January 21, 2011

    Report

    Report Number
    1119421-2011-00052
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    January 1, 2009
    Report Date
    December 22, 2010
    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

    PRODUCT EVALUATION: 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. ROOT CAUSE: NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. NO SAMPLE WAS RETURNED. ACTION TAKEN: NO FURTHER ACTION IS WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MANAGEMENT PERSONNEL. ADDITIONAL INFO WAS REQUESTED ON 12/23/2010 AND 01/05/2010 BY PHONE, FAX, AND MAIL. ADDITIONAL INFO WAS RECEIVED BY PHONE ON 01/19/2011. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT HER INTRAOCULAR LENS (IOL) DISLOCATED TWO TIMES SINCE IMPLANT SURGERY IN 2005. THE FIRST DISLOCATION OCCURRED IN 2009 AND A REPOSITIONING WAS PERFORMED. SHE REPORTED THAT, SINCE THEN, SHE HAS BEEN DIAGNOSED WITH OPTIC NERVE DAMAGE AND GLAUCOMA WHICH HAVE CAUSED VISION LOSS. THE SECOND DISLOCATION OCCURRED "A FEW WEEKS AGO" ((B)(6) 2010) - THE SURGEON TOLD HER THAT THE "LENS HAS COME OUT OF THE BAG". SHE REPORTED THAT THE SURGEON TOLD HER ALL HER ISSUES WERE UNRELATED TO THE IOL. IN A FOLLOW-UP, THE SURGEON CONFIRMED THAT HE DOES NOT BLAME THE LENS FOR THE EVENT; RATHER THE PATIENT'S HISTORY OF DISCONTINUOUS RHEXIS IS THE CAUSE OF THE LENS COMING OUT OF THE CAPSULE. THE PT ALSO HAS A HISTORY OF UVEITIS AND BLEPHARITIS. HE REPORTED THAT HE WAS NOT THE IMPLANTING SURGEON. IN A FOLLOW-UP WITH THE IMPLANTING SURGEON, HIS PERSONNEL INDICATED THAT THE PT HAS NOT BEEN SEEN IN THEIR CLINIC SINCE 2007. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60AT 881858

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention