BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1844692 · Received September 23, 2010

    Report

    Report Number
    1119421-2010-01048
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    January 1, 2006
    Report Date
    August 24, 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
    MI, 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 08/27/2010 AND 08/30/2010 BY PHONE, FAX, AND MAIL. MEDICAL RECORDS WERE REC'D ON 08/30/2010. A COMPLETED QUESTIONNAIRE HAS NOT BEEN REC'D. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED EXPERIENCING DIPLOPIA FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES. MEDICAL RECORDS WERE REC'D AND INDICATED THAT THE CONSUMER ALSO EXPERIENCED BLURRY VISION (IN 2006) AND THAT YAG LASER PROCEDURES WERE PERFORMED IN 2006. IN 2007, THE CONSUMER ALSO PRESENTED WITH DECREASED VISION AND WATERY EYES. IN 2009 AND 2010, DECREASED VISION AND DIPLOPIA CONTINUE; AS WELL AS, IRRITATION AND WATERY EYES WHICH THE SURGEON INDICATED AS A RESULT OF ECTROPIA. THE RECORDS INDICATED THAT THE IOLS ARE STABLE AND IN GOOD POSITION. THE CONSUMER WAS PRESCRIBED BIFOCAL GLASSES WITH PRISM FOR CORRECTION. ADD'L INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60AT 856132

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention PRED FORTE| OCUFLOX| BSS| AMVISC| ASPIRIN| UNPRESERVED LIDOCAINE