BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3893604 · Received May 12, 2014

    Report

    Report Number
    2028159-2014-01100
    Event Type
    Injury
    Date Received
    May 12, 2014
    Report Date
    May 1, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM. UNRELATED TO THE REPORTED EVENT THE COMPANY REPRESENTATIVE REPLACED THE TRAY ARM. THE COMPANY REPRESENTATIVE THEN TESTED THE SYSTEM. A PREVENTIVE MAINTENANCE (PM) WAS PERFORMED. THE SYSTEM MET ALL PRODUCT SPECIFICATIONS. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADDITIONAL INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS INDICATED 1 ADDITIONAL RELATED SIMILAR REPORT FOR THIS SYSTEM. A CLINICAL ANALYST REVIEWED THIS COMPLAINT AND STATED THE FOLLOWING: "CORNEAL THERMAL INJURIES ARE TYPICALLY RELATED TO EXCESSIVE HEAT GENERATED BY THE PHACO TIP DUE TO INSUFFICIENT ASPIRATION FLOW, EXTENDED ENERGY APPLICATION, OR COMBINATION OF BOTH. THE INFINITI VISION SYSTEM IS DESIGNED TO COOL THE PHACO TIP DURING USE AS ASPIRATED FLUID FLOWS THROUGH THE TIP LUMEN. OVERHEATING OF THE PHACO TIP, HOWEVER, MAY OCCUR DUE TO EXTENDED APPLICATION OF ULTRASONIC ENERGY OR COMPROMISED ASPIRATION FLOW THROUGH THE PHACO TIP. REDUCED FLUID FLOW THROUGH THE PHACO TIP MAY BE CAUSED BY PHACO TIP RE-USE, TIP CLOGGING BY NUCLEAR MATERIAL, KINKED TUBING, INADEQUATE FLOW AND VACUUM SETTINGS, OR OBSTRUCTION BY OPHTHALMIC VISCOELASTIC DEVICE (OVD). WHEN THE PHACO TIPS IS OCCLUDED, INFUSION WILL CEASE, REDUCING THE COOLING EFFECT OF THE TIP. OCCLUSION TONES (INTERMITTENT BEEPING TONES DURING OCCLUSION) ALERT THE USER, INDICATING THAT THE VACUUM IS NEAR OR AT ITS PRESET LIMIT, AND ASPIRATION FLOW IS REDUCED OR STOPPED. THE SURGEON MUST RECOGNIZE THE OCCLUSION TONES AND MANUALLY STOP THE ULTRASOUND MODE IN ORDER TO PREVENT A RAPID TEMPERATURE INCREASE. CORNEAL BURN IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. ACCORDING TO THE (B)(4): PREVENTING CORNEAL BURNS DURING PHACOEMULSIFICATION, 03/2010, VOL. 7, NO. 1: 23-25, MOST CORNEAL BURNS CAN BE TRACED TO ISSUES RELATED TO SURGICAL TECHNIQUE AND NOT TO MALFUNCTIONING EQUIPMENT. A ROOT CAUSE CANNOT BE DETERMINED . (B)(4).

    Description of Event or Problem · 1

    A CLINICAL MANAGER REPORTED THAT A CORNEAL BURN OCCURRED AND REQUESTED THAT THE UNIT BE CHECKED OUT. ADDITIONAL INFO WAS REQUESTED BUT HAS NOT YET BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283854 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other INFINITI HANDPIECE