BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1031122 · Received April 18, 2008

    Report

    Report Number
    1119421-2008-00255
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 19, 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
    VT, 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 ARE NO OTHER REPORTS IN THIS LOT NUMBER. THE REPORTER STATED THE EXPLANTED IOL WAS SENT TO A SEPARATE FACILITY FOR TESTING. THE PRODUCT AND THE TEST RESULTS WERE REQUESTED FROM THE REPORTING SURGEON. ADDITIONAL INFORMATION WAS REQUESTED ON 03/21/2008 AND 03/24/2008 BY PHONE, ON 03/25/2008 BY MAIL AND BY FAX AND ON 03/26/2008 BY EMAIL. ADDITIONAL INFO HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTED ON A WEB CHAT-LINE THAT A PT'S INTRAOCULAR LENS (IOL) WAS EXPLANTED, DUE TO THE PT'S COMPLAINT OF NEGATIVE DYSPHOTOPSIA AND UNWANTED VISUAL SENSATIONS FOLLOWING CATARACT EXTRACTION AND IOL IMPLANT SURGERY. THE FOLLOWING SYMPTOMS BEGAN SHORTLY AFTER THE INITIAL IMPLANT SURGERY OVER THREE YEARS AGO: BLURRED VISION, DIFFICULTY READING, PROBLEMS SEEING AT NIGHT, A DARK TEMPORAL LINE, STROBE LIGHT FLASHES TEMPORARILY AND BUBBLE LIGHTS THAT PULSATE. THE IOL WAS REPORTED TO BE IN GOOD POSITION WITH 4+ GLISTENING BODIES. SOME OF THE GLISTENINGS WERE NOTED TO BE IN CLUSTERS. THE IOL WAS EXPLANTED IN 2008. THE PT WAS SEEN BY SEVERAL SURGEONS FOR THEIR OPINIONS PRIOR TO SEEING THIS SURGEON. 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 824870

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention