BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2930867 · Received January 24, 2013

    Report

    Report Number
    2028159-2013-00105
    Event Type
    Injury
    Date Received
    January 24, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 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
    VA, US
    Reporter Occupation
    OTHER

    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 INDICATE TWO SIMILAR REPORT(S) FOR THIS SYSTEM. CORNEAL BURN IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. ACCORDING TO THE (B)(6) PT 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 CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A REGISTERED NURSE REPORTED A PT EXPERIENCED A THERMAL BURN DURING A CATARACT WITH INTRAOCULAR LENS IMPLANT PROCEDURE. THE SYSTEM AND HANDPIECE (H/P) BOTH PRIMED AND TURNED PROPERLY PRIOR TO SURGERY. DURING SURGERY, THE OCCLUSION ALARM SOUNDED AND THE SURGEON PULLED THE PHACOEMULSIFICATION H/P FROM EYE. THE TECHNICIAN FLUSHED THE H/P AND LOOSENED AND RETIGHTENED THE TIP. THE SURGEON WAS ABLE TO FINISH CASE WITHOUT ANY FURTHER OCCLUSION ALARM. ONE SUTURE WAS PLACED TO ENSURE WOUND CLOSURE. A QUESTIONNAIRE WAS SENT TO OBTAIN ADDITIONAL INFORMATION, BUT HAS NOT BEEN RETURNED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34083 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OZIL TORSIONAL PHACO HANDPIECE