BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYCLO G6 LASER SYSTEM

    MDR report key: 14528297 · Received May 27, 2022

    Report

    Report Number
    2939653-2022-00013
    Event Type
    Injury
    Date Received
    May 27, 2022
    Date of Event
    April 27, 2022
    Report Date
    April 25, 2024
    Manufacturer
    IRIDEX CORPORATION
    Product Code
    HQF
    UDI-DI
    00813125015220
    PMA / PMN Number
    K143154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS PROVIDED TO UPDATE THE FOLLOWING: 1) PART B: B5 -PRODUCT PROBLEM SECTION WAS UPDATED. 2) REPORT C: IS THIS A COMBINATION PRODUCT - NO 3) REPORT D: UPDATES TO SECTION D8, D9, D4 4) PART H: UPDATE TO INCLUDE THAT THIS A CORRECTION AND ADDITIONAL INFORMATION REPORT 5) PART D: UPDATED THIS SECTION WITH THE UDI NUMBER. 6) PART E: UPDATES TO THE INITIAL REPORTER SECTION WITH INFORMATION REGARDING THE COMPLAINANT . NOTE: PATIENT INFORMATION WAS NOT PROVIDED, THEREFORE PART A IS NOT FILLED OUT.

    Description of Event or Problem · 0

    IRIDEX BECAME AWARE OF A PATIENT EXPERIENCING MACULAR HOLES DURING TREATMENT WITH A CYCLO G6 LASER SYSTEM. BASED ON THE INFORMATION PROVIDED, IT APPEARS THE TREATMENT WAS PERFORMED WITHIN SPECIFICATIONS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CLINIC OR TREATING PHYSICIAN. BASED ON SIMILAR REPORTED EVENTS, THE MOST LIKELY CAUSE OF THE ISSUE IS SUSPECTED TO BE CONTAMINATION (E.G. BLOOD, TISSUE OR BETADINE) ON THE PROBE TIP WHEN THE LASER WAS ACTIVATED OR LASER ACTIVATION WHEN THE PROBE IS OVER PIGMENTED CONJUNCTIVAL TISSUE. ENGINEERING FAILURE ANALYSIS COULD NOT BE PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. IRIDEX WILL CONTINUE TO FOLLOW-UP WITH THE DOCTOR FOR INFORMATION REGARDING PATIENT RECOVERY.

    Description of Event or Problem · 0

    IRIDEX BECAME AWARE OF A PATIENT EXPERIENCING MACULAR HOLES DURING TREATMENT WITH A CYCLO G6 LASER SYSTEM. BASED ON THE INFORMATION PROVIDED, IT APPEARS THE TREATMENT WAS PERFORMED WITHIN SPECIFICATIONS. BASED ON SIMILAR REPORTED EVENTS, THE MOST LIKELY CAUSE OF THE ISSUE IS SUSPECTED TO BE CONTAMINATION (E.G. BLOOD, TISSUE OR BETADINE) ON THE PROBE TIP WHEN THE LASER WAS ACTIVATED OR LASER ACTIVATION WHEN THE PROBE IS OVER PIGMENTED CONJUNCTIVAL TISSUE. THE MICROPULSE P3 IFU CONTAINS INSTRUCTIONS FOR INSPECTING AND CLEANING THE DEVICE TIP DURING USE, AND THE IFU CONTAINS THE WARNING THAT "CONTAMINATION OF THE DEVICE TIP WITH BLOOD OR TISSUE OF THE FIBER OPTIC BY BLOOD OR TISSUE CHAR CAN RESULT IN SURFACE BURNS IN THE EYE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227075 CYCLO G6 LASER SYSTEM LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF HQF IRIDEX CORPORATION 66245 00813125015220

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other