BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAUREATE WORLD PHACO SYSTEM

    MDR report key: 1051084 · Received May 22, 2008

    Report

    Report Number
    2028159-2008-00181
    Event Type
    Injury
    Date Received
    May 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    ALCON- IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO INDICATION OF ANY ISSUES WITH THE SYSTEM OR CONSUMABLES USED. THE SURGEON BELIEVES THE ISSUE IS RELATED TO USING AN INCISION SIZE AND CONSOLE SETTINGS BASED ON SETTINGS FOR A DIFFERENT SYSTEM. HE HAD BECOME ACCUSTOMED TO THE SETTINGS AND WAS LIKELY OVERLY AGGRESSIVE FOR TRADITIONAL ULTRASOUND. A REVIEW OF COMPLAINT AND SERVICE DATA FOR THE SYSTEM INDICATES THAT THERE HAVE BEEN NO ADDITIONAL COMPLAINTS OR SERVICE REQUESTS RELATED TO THE REPORTED EVENT. COMPLAINT TRENDING INDICATES NO RECENT ADVERSE TRENDS ASSOCIATED WITH THE COMPLAINT. THE ROOT CAUSE OF THE PT EVENT CANNOT BE DETERMINED IN THIS INVESTIGATION. CORNEAL BURN IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. ACCORDING TO THE ECRI HEALTH DEVICES, HAZARD UPDATE: SCLERAL AND CORNEAL BURNS DURING PHACOEMULSIFICATION, NOVEMBER 1996 VOL.25, NO. 11: 426-431, MOST CORNEAL BURNS CAN BE TRACED TO ISSUES RELATED TO SURGICAL TECHNIQUE AND NOT TO MALFUNCTIONING EQUIPMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CORNEAL BURN. THE SURGEON SUTURED THE INCISION SITE AND DESCRIBED THE BURN AS "MINOR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAUREATE WORLD PHACO SYSTEM OPHTHALMIC SURGERY SYSTEM HQC ALCON- IRVINE TECHNOLOGY CENTER LAUREATE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention