BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2939653-2018-00005

    MDR report key: 7360175 · Received March 21, 2018

    Report

    Report Number
    2939653-2018-00005
    Event Type
    Injury
    Date Received
    March 21, 2018
    Date of Event
    October 13, 2017
    Report Date
    March 12, 2018
    PMA / PMN Number
    K170718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SEVERAL POTENTIAL CAUSES OF THE REPORTED EVENTS WERE IDENTIFIED, BUT THE ACTUAL CAUSE IS NOT DEFINITIVE. THE IMMEDIATE AND LONG TERM HEALTH RISK IS DEFINED BY THE SEVERITY OF INJURIES REPORTED BY THE PHYSICIAN AT SLOAN KETTERING. HOWEVER, WHETHER THROUGH USE ERROR, DEVICE DESIGN, ISSUES WITH LABELING AND TRAINING, OR UNIQUE PATIENT ANATOMY, IF THE LIO DEVICE DELIVERS LASER ENERGY TO AN UNINTENDED TARGET, THE RISK SEVERITY (SERIOUSNESS OF HARM) IS "RESULTS IN PERMANENT IMPAIRMENT OF BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE." BECAUSE THE ROOT CAUSE IS UNKNOWN AND THE PROBABILITY OF OCCURRENCE CANNOT BE DETERMINED BUT THE SEVERITY OF HARM RESULTING FROM LASER DELIVERY TO AN UNINTENDED TARGET IS HIGH, IRIDEX HAS MADE A CORPORATE DECISION TO CONDUCT A VOLUNTARY RECALL OF THE TRUFOCUS LIO PREMIERE. RECALL REPORT # 2939653-02/27/2018-001-R.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED "AIMING/TREATMENT BEAM REFLECTIONS AND BURNS" AFFECTING THREE SEPARATE PATIENTS. THE PHYSICIAN WAS USING AN IRIDEX OCULIGHT SLX LASER CONSOLE DELIVERING 810NM LASER THROUGH A TRUFOCUS LIO PREMIER TO TREAT PEDIATRIC PATIENTS HAVING MELANOMAS (INTRA-OCULAR TUMORS, RETINOBLASTOMA). THE PHYSICIAN STATED THAT THE LASER ENERGY WAS NOT GOING WHERE HE INTENDED TO PUT IT WHICH RESULTED IN PERMANENT, FOCAL CATARACTS AND PERMANENT DAMAGE TO THE IRIS OF EACH PATIENT. THE PHYSICIAN REPORTED SEEING "REFLECTIONS" OR "RED STREAKS" OF THE LIO AIMING BEAM DURING THE PROCEDURES. THIS MDR IS BEING SUBMITTED IN ORDER TO PROVIDE 3 SEPARATE MDR'S FOR EACH OF THE 3 PATIENTS REPORTED BY THE PHYSICIAN. THE FIRST MDR (#2939653-2017-00015) WAS SUBMITTED ON 11/10/2017 TO INFORM FDA OF THE 3 PATIENTS. HOWEVER, IRIDEX SHOULD HAVE SUBMITTED 3 SEPARATE MDR REPORTS, SO THIS MDR IS RETROSPECTIVE FOR PATIENT #3 (MDR #2939653-2018-00004 WAS SUBMITTED ON 03/12/2018 FOR PATIENT #2).

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Disability