BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1061310 · Received June 13, 2008

    Report

    Report Number
    1119421-2008-00437
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 14, 2008
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 05/19/2008, AND 05/05/30/2008 BY PHONE, FAX AND MAIL. ADDITIONAL INFORMATION WAS RECEIVED 05/16/2008, 05/20/2008, 05/30/2008 AND 06/02/2008. THIS REPORT WAS MAILED TO FDA ON: 06/13/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT SIX WEEKS FOLLOWING UNCOMPLICATED INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PATIENT REPORTED EYE PAIN. UPON EXAMINATION, THE SURGEON OBSERVED THAT PART OF THE HAPTIC WAS POKING THROUGH THE IRIS. THE PATIENT WAS TREATED WITH MEDICATIONS AND NOTED IMPROVEMENT. AT A FOLLOW-UP VISIT, AN EXAM REVEALED THAT THE HAPTIC WAS BROKEN OFF THE LENS AND WAS LYING IN THE ANTERIOR CHAMBER. IN A FOLLOW-UP, THE SURGEON REPORTS THAT THE LENS WAS EXCHANGED. AT ONE WEEK POSTOPERATIVELY, THE PATIENT HAD MINOR LOCAL EDEMA AT THE WOUND AND THE REPLACEMENT LENS IS IN GOOD POSITION. THE OUTCOME OF EVENT WAS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON MA60AC 10707654

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention