BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2161831 · Received July 8, 2011

    Report

    Report Number
    2028159-2011-00775
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 8, 2011
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM, USING THE CUSTOMER SET UP AND HANDPIECE, AND COULD NOT DUPLICATE THE CUSTOMER REPORTED EVENT. THE SYSTEM WAS THEN TESTED AND MET PRODUCT SPECIFICATIONS. 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 INDICATE 2 SIMILAR REPORTS FOR THIS SYSTEM. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A SURGICAL TECHNICIAN REPORTED, A PATIENT RECEIVED A CORNEAL BURN. ADDITIONAL INFORMATION WAS LATER RECEIVED REPORTING THE PATIENT IS RECOVERING SLOWLY, BUT DOING WELL. A COMPLETED QUESTIONNAIRE WAS RETURNED AND INDICATED THE CORNEAL BURN WAS NOTED DURING PHACOEMULSIFICATION. NO OCCLUSION BELL WAS HEARD BY THE STAFF. THE CASE WAS COMPLETED AND TWO SUTURES WERE USED TO CLOSE THE WOUND. THE PATIENT'S PROGNOSIS WAS REPORTED AS "GOOD".

    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 68 YR Required Intervention VISCOAT