BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1061314 · Received June 13, 2008

    Report

    Report Number
    2028159-2008-00219
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 15, 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
    RO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. 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 MALFUNCTION EQUIPMENT. A LETTER AND COPY OF THIS INDUSTRY ARTICLE WAS PROVIDED TO THE AFFILIATE TO SHARE WITH THE CUSTOMER. THIS REPORT MAILED IN TO FDA ON: 06/13/2008.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT DURING PHACOEMULSIFICATION, A CORNEAL BURN OCCURRED AT THE INCISION SITE. THE DOCTOR WAS ABLE TO COMPLETE THE SURGERY AND IMPLANT THE INTRAOCULAR LENS. THREE SUTURES WERE USED TO CLOSE THE INCISION, AND ASTIGMATISM WAS OBSERVED. THE DOCTOR STATED THAT THE CORNEAL WOUND BURN WAS PRODUCED BY THE ULTRASOUND. THE PT OUTCOME IS REPORTED AS POOR, BUT THE PROGNOSIS IS LISTED AS GOOD.

    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 77 YR Required Intervention