BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3193132 · Received June 25, 2013

    Report

    Report Number
    2028159-2013-01225
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    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
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID NOT REQUEST SERVICE. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION 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 DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE SYSTEM IS EQUIPPED WITH VISUAL AND AUDIBLE WARNING SIGNALS TO ALERT THE USER OF AN OCCLUSION; HOWEVER, THE SURGEON MUST RECOGNIZE THE SIGNAL AND MANUALLY STOP THE ULTRASOUND MODE. THE SYSTEM ALSO ALLOWS THE SURGEON TO MODULATE ULTRASOUND ENERGY. CORNEAL BURN IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. ACCORDING TO THE ()(B)(4) PATIENT SAFETY ADVISORY ABSTRACT: PREVENTING CORNEAL BURNS DURING PHACOEMULSIFICATION, MARCH 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 CUSTOMER REPORTED THAT DURING A CATARACT PROCEDURE, A PATIENT EXPERIENCED A CORNEAL BURN. THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287924 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other