BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2963427 · Received February 13, 2013

    Report

    Report Number
    2028159-2013-00218
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND NO PROBLEMS WERE FOUND. THE COMPANY REPRESENTATIVE EVALUATED THE SYSTEM AND HANDPIECE TO ENSURE THERE WAS NO OBSTRUCTION OF FLOW (INSUFFICIENT IRRIGATION), WHICH THE SURGEON BELIEVED COULD BE A CONTRIBUTING FACTOR TO THE REPORTED EVENT. THE COMPANY REPRESENTATIVE CONFIRMED THE SYSTEM OPERATED AS EXPECTED AS THE SYSTEM IMMEDIATELY EMITTED THE OCCLUSION TONE WHEN AN OCCLUSION CONDITION WAS SIMULATED WITH THE CUSTOMER HANDPIECE. THE SOFTWARE WAS UPDATED. PREVENTION MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. A REVIEW OF THE SYSTEM'S EVENT LOG FOR THE REPORTED DATE OF THE EVENT DID NOT REVEAL ANY SYSTEM MESSAGE OR UNUSUAL EVENTS CAPTURED THAT WOULD SUPPORT A STATEMENT OF INSUFFICIENT IRRIGATION. 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. 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, (B)(6) 2010, VOL. 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 CLINICAL DIRECTOR REPORTED THAT A CORNEAL BURN OCCURRED DURING THE SEGMENT REMOVAL PORTION OF A CATARACT PROCEDURE, RESULTING IN A "SIGNIFICANT DELAY". AS INDICATED IN A RETURNED QUESTIONNAIRE, THE SURGEON FELT THAT INSUFFICIENT IRRIGATION MAY HAVE CONTRIBUTED TO THE BURN. THE SURGEON ALSO NOTED THAT NO OCCLUSION BELL WAS OBSERVED. AS A RESULT OF THE EVENT, THE PATIENT EXPERIENCED A SLIGHT WOUND LEAK, WHICH REQUIRED THREE INTERRUPTED SUTURES TO CLOSE AND PLACEMENT OF A SOFT BANDAGE CONTACT LENS. THE PATIENT ALSO EXPERIENCED HIGH ASTIGMATISM, CORNEAL OPACITY, AND GLARE. THE PATIENT FELT THAT THE GLARE FROM THE ASTIGMATISM WAS AFFECTING HIS LIVELIHOOD, THEREFORE TEMPORARY GLASSES WERE PRESCRIBED. THE SURGEON INDICATED THAT A RIGID GAS PERMEABLE CONTACT LENS FITTING WILL BE PERFORMED ONCE THE CORNEA HAS STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64232 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention