BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPULSE P3 DEVICE

    MDR report key: 23818842 · Received December 16, 2025

    Report

    Report Number
    2939653-2024-00027
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    March 14, 2024
    Report Date
    December 16, 2025
    Manufacturer
    IRIDEX CORPORATION
    Product Code
    GEX
    UDI-DI
    00813125015251
    PMA / PMN Number
    K143154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONJUNCTIVAL/SCLERAL BURNS RESOLVE WITHIN 24 TO 48 HOURS. THEREFORE, UNLESS EITHER MEDICAL INTERVENTION OR PERMANENT IMPAIRMENT ARE REPORTED, SCLERAL BURNS ARE NOT DEEMED A SERIOUS ADVERSE EVENT, BECAUSE SCLERAL BURNS TYPICALLY: DO NOT RESULT IN LIFE-THREATENING ILLNESS OR INJURY, DO NOT RESULT IN PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR A BODY FUNCTION, DO NOT REQUIRE HOSPITALIZATION OR PROLONGATION OF PATIENT HOSPITALIZATION, DO NOT REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION.

    Description of Event or Problem · 0

    IRIDEX BECAME AWARE OF A PATIENT INCIDENT INVOLVING A CONJUNCTIVAL BURN REPORTED BY PHYSICIAN SURGERY CENTER OF ALBUQUERQUE USING A MICROPULSE P3 PROBE AND CYCLO G6 LASER CONSOLE. CYCLO G6 LASER CONSOLE RETURNED TO IRIDEX FOR SERVICING. DURING TECHNICAL INSPECTION, THE CONSOLE PASSED VISUAL INSPECTION AND RFID JUMPER FIBER DETECTION. NO ERROR CODES INDICATING MALFUNCTION WERE DISPLAYED. THE LASER CONSOLE ALSO PASSED THE POWER REQUIREMENTS, AND NO ANOMALIES WERE OBSERVED. PROBES NOT RETURNED TO IRIDEX FOR TECHNICAL INSPECTION. PROBES NOT SERVICED BY IRIDEX AND ARE CONSIDERED BIOHAZARDOUS ONCE USED. IT IS RECOMMENDED TO DISCARD THEM POST TREATMENT ON A PATIENT. CONJUNCTIVAL BURNS ARE A KNOWN POTENTIAL HARM ASSOCIATED WITH THE USE OF LASER DELIVERY IN OPHTHALMIC INDICATIONS. POSSIBILITY OF CONJUNCTIVAL BURN ARE LISTED IN BOTH THE IFU INCLUDED IN MP3 DELIVERY DEVICE AS WELL AS WITHIN THE CYCLO G6 LASER OPERATING MANUAL DUE TO HEATING UP THE TIP OF THE PROBE USED TO DELIVERY THE LASER POWER. THE PROCEDURE WAS PERFORMED USING A TREATMENT SETTING OF 2250 MW WITH AN EXPOSURE TIME OF 15-20 SECONDS PER HEMISPHERE, APPLYING 4-5 SWEEPS. THESE PARAMETERS FALL WITHIN THE RANGE SUGGESTED IN THE MP3 IFU, WHICH RECOMMENDS 2000-2500 MW POWER, 10-20 SECONDS PER SWEEP, AND 3-5 PASSES PER QUADRANT. INTRAOPERATIVELY, THERE WAS NO SUB-CONJUNCTIVAL HEMORRHAGE OR BLEEDING OBSERVED IN THE SURGICAL FIELD. POST-PROCEDURE, BETADINE SOLUTION WAS ADMINISTERED, AND THE PATIENT REPORTED NO FURTHER COMPLICATIONS. ANOTHER FACTOR TO BE TAKEN INTO ACCOUNT IS THAT OCCASIONALLY, THE TIP OF THE PROBE WILL BECOME CONTAMINATED WITH BLOOD OR TISSUE, AND THE CONTAMINANTS ON THE TIP CAN BECOME HATED WHEN EXPOSED TO LASER ENERGY. CONTAMINATION OF THE FIBER OPTIC TIP BY BLOOD OR TISSUE CHAR MAY RESULT IN OCULAR SURFACE BURNS AND A SMOKING TIP OF THE PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1942588 MICROPULSE P3 DEVICE MP3 GEX IRIDEX CORPORATION 00813125015251

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Other