BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 20000 LEGACY

    MDR report key: 1153243 · Received September 5, 2008

    Report

    Report Number
    2028159-2008-00328
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    July 23, 2003
    Report Date
    August 7, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE WAS NOT NOTIFIED OF THE EVENT AND THE CUSTOMER DID NOT REQUEST SERVICE AFTER THE REPORTED EVENT. THE ROOT CAUSE OF THE PATIENT EVENT CANNOT BE DETERMINED IN THIS INVESTIGATION. POSTERIOR CAPSULE TEAR IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. HOWEVER, A REVIEW OF THE COMPLAINT TRENDS SHOWS THAT THE FREQUENCY REPORTED IS WITHIN KNOWN LEVELS FOR THIS EVENT. THIS REPORT WAS MAILED TO FDA ON: 09/05/2008.

    Description of Event or Problem · 1

    A SUMMONS RECEIVED BY THE ALCON LEGAL DEPARTMENT REPORTED THE POSTERIOR CAPSULE WAS RUPTURED DURING THE PATIENT'S CATARACT PROCEDURE. THE SUMMONS ALSO REPORTS THAT THE INFUSION BECAME DISCONNECTED FROM THE HANDPIECE AND BLEW PART OF THE CATARACT INTO THE BACK OF THE EYE. THE PATIENT UNDERWENT A VITRECTOMY SUBSEQUENTLY AND THE SURGEON FOUND A RETINAL DETACHMENT DURING THE VITRECTOMY. THE PATIENT HAS PERMANENT AND SEVERE VISUAL IMPAIRMENT OF THE RIGHT EYE, CONSTANT PAIN OF THE RIGHT EYE, AND AN INABILITY TO FULLY OPEN THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 20000 LEGACY PHACOFRAGMENTATION SYSTEM HQE ALCON - IRVINE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention| S