BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCULIGHT SLX

    MDR report key: 6196867 · Received December 21, 2016

    Report

    Report Number
    2939653-2016-00008
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    August 12, 2016
    Report Date
    August 16, 2016
    Manufacturer
    IRIDEX CORPORATION
    Product Code
    GEX
    PMA / PMN Number
    K020374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, THE DEVICE HAD NOT YET BEEN RETURNED FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND ANALYZED. ADDITIONALLY, SHOULD ANY OTHER INFORMATION BE RECEIVED PERTINENT TO THIS EVENT, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON AUGUST 19, 2016, IRIDEX CORP. WAS INFORMED OF AN ADVERSE EVENT WHICH OCCURRED AFTER A LASER PROCEDURE FOR PHOTOCOAGULATION OF RETINOPATHY OF PREMATURITY (ROP) USING THE IRIDEX OCULIGHT SLX LASER AND LIO+ LASER INDIRECT OPHTHALMOSCOPE. THE PATIENT WAS A FEMALE INFANT APPROXIMATELY 46 WEEKS CORRECTED GESTATIONAL AGE(ABOUT 20 WEEKS POST-DELIVERY). IT WAS REPORTED THAT THE PATIENT HAD MINIMAL HEALTH ISSUES HAVING BEEN ADMITTED TO THE (NEONATAL INTENSIVE CARE UNIT) NICU FOR A FEW WEEKS POST-DELIVERY. ON (B)(6) 2016, THE PATIENT WAS TREATED FOR ROP IN THE LEFT EYE WITH NO REPORTED COMPLICATIONS. ON (B)(6) 2016, THE PATIENT WAS SCHEDULE TO UNDERGO LASER PHOTOCOAGULATION TO TREAT ROP OF THE RIGHT EYE. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE POWER SETTINGS ON THE LASER WERE REPORTED TO BE BETWEEN 80-130 MW, DURATION OF 150 MILLISECONDS (MSEC) AND AN AUTOMATIC REPEAT AT 300 MSEC. IT WAS REPORTED THAT THESE SETTINGS WERE THE SAME SETTINGS USED DURING THE (B)(6) 2016 PROCEDURE. THE TREATING PHYSICIAN REPORTED LASERING AT THE 6 O'CLOCK POSITION AND PROCEEDING CLOCKWISE. THE PHYSICIAN PUT OVER 1000 SHOTS IN THE EYE AND WAS NEARING COMPLETION OF THE PROCEDURE WHEN THERE WAS A SINGLE INTENSE LASER SHOT WHICH CAUSED A BREAK IN THE RETINA AT APPROXIMATELY THE 5 O'CLOCK POSITION. IT WAS REPORTED THAT THE AUTOMATIC REPEAT MODE STOPPED (THE FOOT PEDAL STOPPED FIRING), THE LASER WENT INTO A PAUSE MODE, AND THE LASER DISPLAY PANEL DISPLAYED "TYPE 1 SERVICE ERROR." THE PHYSICIAN REPORTED THAT AT THIS POINT HE CYCLED THE LASER ON AND OFF. IN ORDER TO TREAT THE BREAK IN THE RETINA, THE PHYSICIAN ADDED A FEW MORE SHOTS AROUND THE SITE. IT WAS REPORTED THAT THE PATIENT HAS BEEN SEEN IN FOLLOW UP BY THE TREATING PHYSICIAN 3-4 TIMES SINCE THE INCIDENT AND THE PATIENT IS DOING FINE WITH NO FURTHER SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844070 OCULIGHT SLX LASER GEX IRIDEX CORPORATION SLX

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Required Intervention LIO+ LASER INDIRECT OPHTHALMOSCOPE