BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1070130 · Received July 3, 2008

    Report

    Report Number
    2028159-2008-00246
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 9, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT REQUEST SERVICE. THE INSTRUMENT SETTINGS PROVIDED WERE REVIEWED AND WERE DETERMINED THAT FROM THE SETTINGS ALONE, THEY COULD NOT HAVE CONTRIBUTED TO THE CORNEAL BURN. NO SAMPLES WERE RETURNED FOR EVAL, AND NO CONCLUSIONS COULD BE MADE FROM THE INFO GIVEN. THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN, AND COULD NOT BE DETERMINED. 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. A LETTER AND COPY OF THIS INDUSTRY ARTICLE WAS PROVIDED TO THE CUSTOMER. THIS REPORT MAILED IN TO FDA ON: 07/03/2008.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT TWO CORNEAL BURNS HAD OCCURRED. THE SURGEON MADE A 2.6 MM INCISION, AND USED A 0.9 MM TAPERED TIP. THE SURGEON STATED THAT 2 OUT OF THE 5 CASES INVOLVED A CORNEAL BURN, AND THEY HAPPENED ON THE FIRST AND FOURTH CASES. THE BURNS WERE NOTED TO BE MILD. ONE STITCH WAS USED IN ALL 5 PATIENTS, AS THE DOCTOR TYPICALLY USES A STITCH. THE CUSTOMER STATED THE PATIENTS WERE EXPECTED TO DO WELL. THIS REPORT IS FOR ONE PT; FOR ADDITIONAL PT SEE MFG. REPORT #: 2028159-2008-00247.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI