BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPULSE P3 PROBE

    MDR report key: 23791068 · Received December 12, 2025

    Report

    Report Number
    2939653-2025-00003
    Event Type
    Injury
    Date Received
    December 12, 2025
    Date of Event
    July 16, 2025
    Report Date
    December 12, 2025
    Manufacturer
    IRDEX CORPORATION
    Product Code
    GEX
    UDI-DI
    00813125016647
    PMA / PMN Number
    K143154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FEEDBACK FROM CUSTOMER: "THE CONJUNCTIVAL BURN THAT OCCURRED WAS MINOR; THE AREA HEALED SPONTANEOUSLY, WITHOUT INTERVENTION, WITHIN SEVERAL DAYS. THERE WAS NO RESIDUAL DAMAGE THAT REMAINED. THE PATIENT'S VISION HAS BEEN LIMITED DUE TO LONGSTANDING EXUDATIVE MACULAR DEGENERATION AND SEVERE GLAUCOMA. THE AE THAT OCCURRED IS UNLIKELY TO HAVE AFFECTED THE PATIENT'S VISION AND HAS RESOLVED COMPLETELY."

    Description of Event or Problem · 0

    IT WAS REPORTED TO IRIDEX THAT WHILE USING THE MICROPULSE P3 PROBE (MP3), THE PATIENT EXPERIENCED CONJUNCTIVAL BURN. THE REPORTED SETTINGS USED FOR TREATMENT WERE CONSISTENT WITH THE MP3 IFU (2500 MW FOR 3.4 SECONDS WITH AN INTERVAL OF 20 SECONDS). NO PERMANENT IMPAIRMENT WAS REPORTED TO IRIDEX, AND NO MEDICAL INTERVENTION ASSOCIATED WITH THE BURN WAS REPORTED TO IRIDEX. THE PROBE, WHICH IS DISPOSABLE, WAS NOT RETURNED TO IRIDEX FOR FURTHER INVESTIGATION. CONJUNCTIVAL BURNS ARE A KNOWN POTENTIAL HARM ASSOCIATED WITH THE USE OF LASER DELIVERY IN OPHTHALMIC INDICATIONS. TYPICALLY, CONJUNCTIVAL 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 CONJUNCTIVAL 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. THE LASER CONSOLE USED WITH THE PROBE WAS THE CYCLO G6 LASER CONSOLE. THE LASER CONSOLE WAS RETURNED TO IRIDEX FOR FURTHER INVESTIGATION. AS PER THE INVESTIGATION, NO PROBLEM WAS FOUND WITH THE CONSOLE AND IT WAS RETURNED TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2702603 MICROPULSE P3 PROBE MP3 GEX IRDEX CORPORATION 15522 00813125016647

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Female Other