BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1905582 · Received November 19, 2010

    Report

    Report Number
    2028159-2010-02228
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. CORNEAL BURN IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. ACCORDING TO THE (B)(6) 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. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTED A CORNEAL BURN OCCURRED. DURING CATARACT SURGERY OF THE LEFT EYE, EVERYTHING WENT SMOOTHLY DURING THE FIRST STEPS OF THE PROCEDURE. WHEN THE SURGEON WAS SCULPTING THE EPICORTEX AND THE BEGINNING OF THE FIRST GROOVE, THE ASPIRATION SUDDENLY STOPPED. A WHITISH VISCOUS PLUG WAS OBSERVED. THE SURGEON THOUGHT HE COULD ASPIRATE IT, SO HE PRESSED DOWN ON THE FOOTSWITCH. ONLY THE PHACO ULTRASOUND WAS AVAILABLE. THERE WAS NO IRRIGATION/ASPIRATION. THE CORNEAL BURN LEAD TO SEIDEL AND SECONDARY HERNIA OF THE IRIS. THE WOUND WAS SUTURED WITH ONE STITCH. ANOTHER SUTURE WAS PLACED 5 DAYS AFTER SURGERY. THE INCISION IS STILL NOT TIGHT. THE WOUND IS HEALING SLOWLY. THE PT REQUIRED HOSPITALIZATION. ADDITIONAL INFORMATION RECEIVED FROM THE SURGEON STATED THE NUCLEUS WAS NOT PARTICULARLY HARD. THE INCISION SIZE 2.2MM. THE SURGEON WAS USING 100% US PHACO POWER TO REMOVE THE VISCOUS PLUG. THE IRRIGATION SOLUTION WAS PREVIOUSLY ICED. THE SURGEON DID NOT CREATE A WORKING SPACE BY REMOVING SOME VISCOELASTIC BEFORE BEGINNING PHACO. THE PT HAD AN AMNIOTIC MEMBRANE GRAFT. THE SURGEON SAW THE PT ON (B)(6) 2010. THE PT'S PROGNOSIS IS STILL UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R