BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPULSE P3 DEVICE

    MDR report key: 23812051 · Received December 15, 2025

    Report

    Report Number
    2939653-2024-00026
    Event Type
    Injury
    Date Received
    December 15, 2025
    Date of Event
    May 2, 2024
    Report Date
    December 15, 2025
    Manufacturer
    IRIDEX CORPORATION
    Product Code
    GEX
    UDI-DI
    00813125015251
    PMA / PMN Number
    K143154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 (CONJUNCTIVAL BURN) USING THE IRIDEX MICROPULSE P3 PROBE (MP3). NO INFORMATION ON THE LASER CONSOLE USED WAS PROVIDED TO IRIDEX. NO DEVICE WAS RETURNED TO IRIDEX FOR SERVICING. PROBE ARE SINGLE USE DEVICES AND ARE CONSIDERED BIOHAZARDOUS ONCE USED. IT IS RECOMMENDED TO DISCARD THEM POST TREATMENT ON A PATIENT. 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 COMPLICATION 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. DURING A CBLT PROCEDURE AT NW EYE SURGEONS, TWO MICROPULSE P3 PROBES (LOT 801086, REF (B)(4), EXP 2026-11-01) EXHIBITED ABNORMAL BEHAVIOR. THE FIRST PROBE DEVELOPED A DARK BROWN TIP WITH YELLOW DISCOLORATION AND CAUSED PATIENT DISCOMFORT AFTER 100 SECONDS AT 3000 MW. THE SWEEP WAS PAUSED, AND A NEW PROBE WAS APPLIED. THE SECOND PROBE ALSO SHOWED EARLY DISCOLORATION AND DISCOMFORT AFTER 80 SECONDS, PROMPTING TERMINATION OF TREATMENT AT 180 SECONDS TOTAL. THE TREATMENT PARAMETERS USED HAVE A POSSIBILITY OF CONJUNCTIVAL BURN. THE PATIENT UNDERGOING CHEMOTHERAPY (CISPLATIN, GEMCITABINE, DURVALUMAB), WHICH MAY HAVE INFLUENCED TISSUE RESPONSE. 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
    324134 MICROPULSE P3 DEVICE MP3 GEX IRIDEX CORPORATION 801086 00813125015251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other