BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2792216 · Received October 12, 2012

    Report

    Report Number
    2028159-2012-01579
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 12, 2012
    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
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID NOT REQUEST SERVICE. HOWEVER, THE CUSTOMER RETURNED A PHACO HANDPIECE FOR EVALUATION. THE HANDPIECE (HP) WAS EXAMINED AND A VISUAL ASSESSMENT OF THE SAMPLE REVEALED A DENTED IRRIGATION LINE AND A SEPARATION OF BOTH STRAIN RELIEFS. THE HP GROUND RESISTANCE, U/S STROKE LENGTH, AND TORSIONAL STROKE LENGTH WERE MEASURED AND FOUND TO BE WITHIN PRODUCT SPECIFICATIONS. THE IRRIGATION AND ASPIRATION PASSAGE FLUIDIC FLOW TEST WAS PERFORMED AND THE FLOW RATES WERE FOUND TO MEET PRODUCT SPECIFICATIONS. THE HP SUCCESSFULLY PRIMED AND TUNED ON A CALIBRATED SYSTEM AND PERFORMED AT 100% PHACO POWER FOR 5 MINUTES WITHOUT ANY OBSERVABLE ISSUES. AN EVALUATION OF THE RETURNED SAMPLE REVEALED SEVERAL COSMETIC NONCONFORMITIES. THERE WERE DENTS ON THE IRRIGATION LINE AND A SEPARATION OF BOTH THE HP AND CONNECTOR STRAIN RELIEFS; HOWEVER, THESE ISSUES ARE NOT RELATED TO THE REPORTED EVENT. THE HP PASSED ALL FUNCTIONAL TESTING AND WAS VERIFIED TO MEET PRODUCT SPECIFICATIONS. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS PHACO HANDPIECE OR SYSTEM. CORNEAL BURN IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. ACCORDING TO THE PENNSYLVANIA 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. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT DURING A PROCEDURE, OCCLUSIONS KEPT OCCURRING AND A PATIENT EXPERIENCED A THERMAL BURN. THE CASE WAS COMPLETED USING AN ALTERNATE HANDPIECE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 Other OZIL TORSIONAL PHACO HANDPIECE