BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRIDEX IQ577 LASER SYSTEM

    MDR report key: 3466409 · Received November 4, 2013

    Report

    Report Number
    2939653-2013-00004
    Event Type
    Injury
    Date Received
    November 4, 2013
    Date of Event
    October 7, 2013
    Report Date
    November 4, 2013
    Manufacturer
    IRIDEX CORP.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGE OF DISPLAY SCREEN AT THE TIME OF END-OF-TREATMENT SHOWED: MICROPULSE MODE; 1.0MS ON; 2.0MS OFF; 33.3% DUTY CYCLE; SPOT SIZE SELECTION IS 200UM; POWER 200MW (PHYSICIAN LATER STATED SHE WAS USING 400MW POWER FOR TREATMENT BUT WAS SO SURPRISED A THE VISIBLE TISSUE RESPONSE THAT SHE IMMEDIATELY REDUCED IT TO 200MW AS DISPLAYED). THIS SAME SCREEN WAS VERIFIED AT A VISIT BY IRIDEX INVESTIGATIONAL TEAM ON (B)(4) 2013. THE IQ577 LASER (SERIAL # (B)(4), MANUFACTURED IN OCTOBER 2011) HAD NOT BEEN USED SINCE THE INCIDENT REPORTED ON (B)(6) 2013. THE LASER WAS TESTED FOR BOTH HARDWARE AND SOFTWARE FUNCTIONS INCLUDING OUTPUTS AT A VARIETY OF SETTINGS INCLUDING THE SETTINGS DISPLAYED ON THE SCREENS AT THE TIME OF TREATMENT AND SET MODE. (I.E. MICROPULSE AND/OR CONTINUOUS WAVE [CW]). THE PRODUCT MET SPECIFICATIONS AND ALL TESTS TO WHICH THE PRODUCT WAS SUBJECTED, PASSED. THE MICROPULSE PARAMETER SETTINGS DISPLAYED ON THE SCREEN ARE QUITE UNUSUAL SETTINGS FOR MOST RETINAL APPLICATIONS. TREATMENT PARAMETERS REPORTED IN THE LITERATURE FOR MICROPULSE AND PRESENTED AS GUIDANCE IN THE OPERATOR MANUAL. THE TREATMENT PARAMETERS DISPLAYED BY THE SCREEN ON THE LASER AER UNUSUAL SELECTIONS FOR THIS PATIENT. THE DUTY CYCLE OF 33.3% IS VERY HIGH FOR MOST RETINAL APPLICATIONS, ESPECIALLY THOSE INVOLVING THE MACULAR REGION WHERE DUTY CYCLES OF 5% OR 10% ARE MUCH MORE FREQUENTLY REPORTED. MOREOVER A MICROPULSE DURATION OF 1.0MS IS VERY LONG, SO CONFINEMENT OF THERMAL ENERGY DURING EACH LASER PULSE WOULD BE MINIMAL WITH TISSUE EFFECTS APPROXIMATING THOSE OBTAINED BY USING CW. THERE WERE NO ERROR MESSAGES DISPLAYED ON THE SCREEN AT EXAMINATION. THERE WAS NO EVIDENCE OF SOFTWARE MALFUNCTION I.E. SET AT MICROPULSE AND GIVE A CW TREATMENT. THE TREATMENT PARAMETERS DISPLAYED CAN ONLY BE THERE IF THEY ARE MANUALLY DIALED. THERE ARE 2 WAYS THAT THIS MAY BE ACCOMPLISHED: THESE PARAMETERS CAN BE DIALED IN BY THE CURRENT USER BY FIRST SELECTING THE MICROPULSE MODE BUTTON (A "CLICK" IS HEARD), THEN SELECTING MICROPULSE "ON" BUTTON, AND FINALLY ADJUSTING BOTH MICROPULSE DURATION AND INTERVAL VALUES WITH THE KNOBS ON THE FRONT OF THE CONSOLE. ALTERNATIVELY, THEY COULD REPRESENT THE MICROPULSE LASER PARAMETERS WHEN THE LASER WAS LAST POWERED DOWN PRIOR TO USE ON THIS PATIENT. THE LAST TREATMENT POWERS (EXCEPT LASER POWER) ARE REMEMBERED AND RESTORED AT EACH LASER POWER-UP.

    Description of Event or Problem · 1

    IRIDEX RECEIVED A TELEPHONE CALL FROM (B)(6) REPORTING AN INCIDENT WHERE A PATIENT HAD BEEN INJURED WHILE RECEIVING A LASER TREATMENT TO THE EYE WITH AN IRIDEX CORP IQ577 LASER AT THEIR FACILITY. THE PATIENT, A FEMALE IN HER (B)(6) IS A PREGNANT TYPE I DIABETIC, WAS RECEIVING TREATMENT FOR DIABETIC MACULA EDEMA. THE PATIENT HAD SUCCESSFULLY BEEN TREATED A FEW WEEKS BEFORE ON THE CONTRA-LATERAL EYE WITH THE SAME LASER. THE TREATING PHYSICIAN INPUT THE TREATMENT PARAMETERS INTO THE LASER AND WAS TREATING THE PATIENT IN MICROPULSE MODE. THE TREATING PHYSICIAN COMMENCED TREATMENT BUT CEASED AFTER DELIVERING 203 PULSES AT 300 MS, WHEN THE PATIENT COMPLAINED ABOUT PAIN. THE TREATING PHYSICIAN STATED THAT THE LASER HAD BEEN SET TO DELIVER MICROPULSE BUT MAY HAVE DELIVERED CW (CONTINUOUS WAVE) INSTEAD RESULTING IN UNEXPECTEDLY HIGH ENERGY DELIVERY TO THE PATIENT'S RETINA WITH THE POTENTIAL LOSS OF SOME CENTRAL VISION. THE TREATING PHYSICIAN IMMEDIATELY ADMINISTERED STEROID EYE DROPS AFTER THIS EVENT OCCURRED AND WAS SCHEDULED TO RETURN THE NEXT DAY ON (B)(6) 2013 FOR FURTHER EVALUATION. THE FACILITY FORWARDED A PHOTOGRAPHIC IMAGE OF THE DISPLAY PANEL ON THE IQ577 TO IRIDEX. THE FACILITY ALSO ASKED IF THE PRODUCT HAD FDA "APPROVAL". A COPY OF THE 510(K) CLEARANCE LETTER (K071687) WITH THE SUMMARY INFORMATION WAS FORWARDED. THE FACILITY HD QUARANTINED THE LASER AND WANTED SOMEONE FROM IRIDEX TO COME TO FACILITY TO EXAMINE THE LASER. THEY DID NOT WANT THE LASER TO BE RETURNED TO IRIDEX. MULTIPLE INQUIRIES HAVE BEEN MADE TO THE FACILITY WITH RESPECT TO THE STATUS OF THE PATIENT. IRIDEX HAS NOT RECEIVED A RESPONSE AS TO THE PATIENT'S RECOVERY, FURTHER TREATMENT AND/OR PROGNOSIS AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565803 IRIDEX IQ577 LASER SYSTEM IRIDEX IQ577 LASER SYSTEM GEX IRIDEX CORP. 65600-01

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other