BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPULSE P3 DEVICE

    MDR report key: 23770008 · Received December 10, 2025

    Report

    Report Number
    2939653-2024-00030
    Event Type
    Injury
    Date Received
    December 10, 2025
    Date of Event
    June 7, 2024
    Report Date
    December 10, 2025
    Manufacturer
    IRIDEX CORPORATION
    Product Code
    GEX
    UDI-DI
    00813125015251
    PMA / PMN Number
    K143154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    IT WAS REPORTED TO IRIDEX THAT WHILE USING THE MICROPULSE P3 PROBE, A PHYSICIAN NOTICED SMOKE COMING OUT OF THE PROBE TIP AND THE PHYSICIAN NOTICED CONJUNCTIVAL BURN. DEVICE WAS NOT RETURNED TO IRIDEX FOR FURTHER INVESTIGATION. OPHTHALMIC LASER SYSTEMS ARE INTENDED TO DELIVER THERMAL (LASER) ENERGY TO DELIVER AN INSULT (BURN) TO THE CILIARY BODY. CONJUNCTIVAL BURNS ARE A KNOWN AND PREDICTED COMPLICATION ASSOCIATED WITH THE USE OF ANY OPHTHALMIC LASER SYSTEM (CONSOLE AND DELIVERY DEVICE) WHEN USED TO DELIVER TRANSSCLERAL TREATMENT. IT IS LISTED AS A POSSIBLE COMNPLICATION IN THE IFU FOR MP3 DELIVERY DEVICE. CONJUNCTIVAL BURNS ARE A SPECIFIC TYPE OF OCULAR BURN THAT CAN OCCUR ALONG WITH CORNEAL BURNS, OFTEN DUE TO CHEMICAL OR THERMAL INJURY AND ARE TYPICALLY SUPERFICIAL, POSING NO LONG-TERM THREAT TO THE PATIENT. TYPICALLY, THESE BURNS RESOLVE WITHIN 24-48 HOURS POST OP WITHOUT ADDITIONAL INTERVENTION. IRIDEX CORPORATION DOES REPORT EVERY ADVERSE EVENT VIA THE FDA'S MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE) DATABASE. THE TREATMENT PARAMETERS REPORTED (1500 MW POWER, 1500 MS PER SWEEP, 5 SWEEPS PER QUADRANT) DIFFER SIGNIFICANTLY FROM THE PARAMETERS SUGGESTED IN THE MP3 IFU (2000-2500 MW POWER, 10-20 SECONDS PER SWEEP, 3-5 PASSES PER QUADRANT). SPECIFICALLY, THE PHYSICIAN USED A SUBSTANTIALLY LOWER POWER SETTING AND MUCH SHORTER SWEEP DURATION, RESULTING IN SIGNIFICANTLY LESS TOTAL TREATMENT ENERGY DELIVERED TO THE EYE. THE PHYSICIAN ADHERED TO THE PROCEDURAL APPROACH (NUMBER OF SWEEPS AND QUADRANT COVERAGE) BUT SELECTED CONSERVATIVE ENERGY SETTINGS. THE PHYSICIAN CHANGED THE PROBE BEING USED AND THERE WAS NO FURTHER ISSUE DURING THE TREATMENT. 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
    2168056 MICROPULSE P3 DEVICE MP3 PROBE GEX IRIDEX CORPORATION 801010 00813125015251

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Other