BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYCLO G6

    MDR report key: 14528471 · Received May 27, 2022

    Report

    Report Number
    2939653-2022-00015
    Event Type
    Injury
    Date Received
    May 27, 2022
    Date of Event
    April 29, 2022
    Report Date
    April 25, 2024
    Manufacturer
    IRIDEX CORPORATION
    Product Code
    HQF
    UDI-DI
    00813125015374
    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 COMPLAINT REPORTING A PATIENT EXPERIENCING CONJUNCTIVAL BURN DURING TREATMENT WITH THE MICROPULSE P3 PROBE. THE TREATMENT WAS PERFORMED WITHIN SPECIFICATIONS. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. 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 WAS NOT PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE MICROPULSE P3 IFU HAS CLEAR INSTRUCTIONS TO EXAMINE THE PROBE TIP BEFORE TREATMENT AND TO AVOID AREAS OF PERILIMBAL PIGMENTATION. PER THE IFU 'EXCESSIVE TREATMENT POWER MAY RESULT IN OCULAR SURFACE BURNS OR CILIARY BODY HEMORRHAGE. CONTAMINATION OF THE FIBER OPTIC TIP BY BLOOD OR TISSUE CHAR MAY RESULT IN OCULAR SURFACE BURNS. EXCESSIVE ENERGY MAY CAUSE EQUATORIAL BURNS. IF THE DEVICES ARE RETURNED AND THE RESULTS OF FAILURE ANALYSIS INDICATE NEW INFORMATION, THE ADVERSE EVENT REPORT WILL BE AMENDED. THE RESULTS OF POST MARKET DATA REVIEW INDICATE THAT THIS FAILURE MODE IS NOT OCCURRING WITH GREATER SEVERITY.

    Description of Event or Problem · 0

    IRIDEX BECAME AWARE OF A COMPLAINT REPORTING A PATIENT EXPERIENCING CONJUNCTIVAL BURN DURING TREATMENT WITH THE MICROPULSE P3 PROBE. THE TREATMENT WAS PERFORMED WITHIN SPECIFICATIONS. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. 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 HAS CLEAR INSTRUCTIONS TO EXAMINE THE PROBE TIP BEFORE TREATMENT AND TO AVOID AREAS OF PERILIMBAL PIGMENTATION. PER THE IFU 'EXCESSIVE TREATMENT POWER MAY RESULT IN OCULAR SURFACE BURNS OR CILIARY BODY HEMORRHAGE. CONTAMINATION OF THE FIBER OPTIC TIP BY BLOOD OR TISSUE CHAR MAY RESULT IN OCULAR SURFACE BURNS. EXCESSIVE ENERGY MAY CAUSE EQUATORIAL BURNS. IF THE DEVICES ARE RETURNED AND THE RESULTS OF FAILURE ANALYSIS INDICATE NEW INFORMATION, THE ADVERSE EVENT REPORT WILL BE AMENDED. THE RESULTS OF POST MARKET DATA REVIEW INDICATE THAT THIS FAILURE MODE IS NOT OCCURRING WITH GREATER SEVERITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158626 CYCLO G6 LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF HQF IRIDEX CORPORATION 66245 00813125015374

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other