BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G-PROBE RFID

    MDR report key: 25087324 · Received May 5, 2026

    Report

    Report Number
    2939653-2026-00003
    Event Type
    Injury
    Date Received
    May 5, 2026
    Date of Event
    March 11, 2026
    Report Date
    May 5, 2026
    Manufacturer
    IRIDEX CORPORATION
    Product Code
    GEX
    UDI-DI
    00851089000227
    PMA / PMN Number
    K143154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS NOTED IN THE SCIENTIFIC LITERATURE, CONJUNCTIVAL/SCLERAL BURNS ARE A KNOWN POTENTIAL HARM ASSOCIATED WITH TRANSSCLERAL DIODE LASER CYCLOPHOTOCOAGULATION. SCLERAL BURNS ARE A KNOWN POTENTIAL ISSUE WITH THE DELIVERY OF LASER ENERGY. THERE WAS NO REPORT OF ANY PERMANENT IMPAIRMENT TO THE PATIENT, AND 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. HOWEVER, SCLERAL PERFORATION, UNLIKE SCLERAL BURN, DOES REQUIRE MEDICAL INTERVENTION. THE PATIENT REQUIRED MEDICAL INTERVENTION CONSISTING OF A SCLERAL SUTURE CLOSURE. THEREFORE, GIVEN THE NECESSITY OF SURGICAL AND/OR MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF THE SCLERA, IRIDEX DETERMINES THE REPORTED SCLERAL PERFORATION TO BE A SERIOUS ADVERSE EVENT (SAE) IN THE USA.

    Description of Event or Problem · 0

    IRIDEX RECEIVED A ADVERSE EVENT REPORT INVOLVING A IRIDEX CYCLO G6 AND A G-PROBE DELIVERY DEVICE. AS PER THE REPORT, DURING CILIARY BODY DESTRUCTION USING TSCPC IN CONTINUOUS WAVE, WHICH IS A TREATMENT TO RESOLVE REFRACTORY GLAUCOMA, THE SURGEON REPORTED SCLERAL PERFORATION IN THE PATIENT'S LEFT EYE. IT WAS REPORTED THAT LASER APPLICATION WAS PERFORMED USING TWO ROWS OF TREATMENT SPOTS. A SUTURE WAS USED TO CLOSE THE PERFORATION. THE SURGEON DISCONTINUED THE USE OF THE DELIVERY DEVICE AND OPENED ANOTHER DELIVERY DEVICE AND WAS ABLE TO FINISH THE LASER PROCEDURE. ALTHOUGH, CONJUNCTIVAL AND SCLERAL BURNS ARE KNOWN AND DOCUMENTED COMPLICATIONS OF TSCPC AND TYPICALLY RESOLVE WITHOUT INTERVENTION WITHIN 24 - 48 HOURS, CONJUNCTIVAL AND/OR SCLERAL PERFORATION ARE NOT CONSIDERED A COMMON OCCURRENCE AND MAY REQUIRE MEDICAL INTERVENTION SUCH AS THE USE OF A SUTURE TO MANAGE THE PERFORATION. THE DELIVERY DEVICE IFU WARNS THE USER OF POTENTIAL CONTRIBUTORS TO SCLERAL BURNS RESULTING IN SCLERAL PERFORATION. THE POSSIBLE CONTRIBUTORS INCLUDE (1) EXCESSIVE POWER AND/OR ENERGY DELIVERED, (2) THE PRESENCE OF BLOOD AND/OR TISSUE BENEATH THE DELIVERY DEVICE FOOTPLATE, (3) THE PRESENCE OF PIGMENT OR PIGMENT-LIKE ANATOMICAL FEATURES AT THE TREATMENT SITE, AND (4) DEVIATIONS FROM STANDARD OPERATING PROCEDURES. THE STANDARD OPERATING TECHNIQUE FOR CONTINUOUS WAVE TSCPC WITH A G-PROBE INVOLVES APPLYING 18 - 21 DISCRETE, EVENLY SPACED LASER SPOTS IN A SINGLE CIRCUMFERENTIAL ROW AROUND THE LIMBAL REGION. THE ADVERSE EVENT DESCRIPTION INDICATES THAT TWO ROWS (OR "PASSES") OF DISCRETE TREATMENT SPOTS WERE APPLIED. THIS APPROACH, I.E., THE APPLICATION OF A SECOND PASS OF TREATMENT SPOTS, MAY HAVE RESULTED IN EXCESSIVE THERMAL EXPOSURE/OVER TREATMENT TO SCLERAL TISSUE AND COULD HAVE POTENTIALLY CONTRIBUTED TO THE SCLERAL PERFORATION. IRIDEX HAS TRIED TO CONTACT THE PHYSICIAN AND FACILITY ON MULTIPLE ACCOUNTS BUT HAVEN'T RECEIVED ANY FEEDBACK OR RESPONSE ON THE SPECIFIC DETAILS OF THE EVENT TILL DATE. IN THE ABSENCE OF ADDITIONAL CLINICAL OR PROCEDURAL INFORMATION, IT CANNOT BE DETERMINED WHETHER THIS TECHNIQUE DEVIATION ALONE, OR IN COMBINATION WITH OTHER KNOWN CONTRIBUTING FACTORS, LED TO THE REPORTED EVENT. AT THIS TIME, NO FURTHER PROCEDURAL DETAILS OR CLINICAL DATA HAVE BEEN PROVIDED. CONSEQUENTLY, THE ROOT CAUSE OF THE ADVERSE EVENT CANNOT BE CONCLUSIVELY DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584704 G-PROBE RFID G-PROBE RFID GEX IRIDEX CORPORATION 11256 200351 00851089000227

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Other