MAUDE Adverse Event Report: IRIDEX CORPORATION G-PROBE RFID

Lot Number	200322
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to iridex that while using the g-probe, the patient experienced scleral burn.The hospital noted that the output power appeared higher than expected; however, subsequent power output testing conducted by the hospital confirmed that the laser power was within specification.No permanent impairment was reported to iridex, and no medical intervention associated with the burn was reported to iridex.The probe (single use and disposable) or the laser console was not returned to iridex for further investigation.Scleral burns are a known potential harm associated with the use of laser delivery in ophthalmic device indications.The laser console used with the probe is the cyclo g6 laser console.Iridex further assessed that the most likely cause of the burns was contamination on the probe tip (e.G., blood, tissue, or betadine), which can heat the probe and cause localized burns.The ifu cautions users to inspect the probe for debris and discontinue use if burns occur.Based on this assessment, iridex did not identify any product safety risk.A review of the reported treatment parameters indicates a deviation from the ifu-recommended "slow coagulation" technique.The ifu suggests using lower power (1250 - 1500 mw) and longer duration (3500 - 4000 ms) to deliver controlled energy of approximately 5 joules per application.In contrast, the reported procedure employed higher power settings (up to 2400 mw) with shorter durations (2000 ms), followed by multiple adjustments down to 1400 mw and 1000 mw with durations of 2 - 4 seconds, all resulting in burns.While the total energy per application was similar to ifu values, the delivery method was more aggressive, potentially increasing the risk of tissue damage.This deviation from recommended parameters, combined with possible probe contamination, may have contributed to the adverse outcome.The investigation concludes that the device operated within specification and did not malfunction.The primary contributing factors appear to be (1) contamination on the probe tip, as suggested by iridex, and (2) deviation from ifu recommended treatment parameters, which may have compounded the risk of burns.

• Brand Name: G-PROBE RFID
• Common Device Name: G-PROBE RFID
• Manufacturer (Section D): IRIDEX CORPORATION; 1212 terra bella avenue; mountain view CA 94043 1824
• Manufacturer (Section G): IRIDEX CORPORATION; 1212 terra bella avenue; mountain view CA 94043 1824
• Manufacturer Contact: bill hyatt ; 1212 terra bella avenue; mountain view, CA 94043-1824 ; 6506058727
• MDR Report Key: 23697106
• Report Number: 2939653-2025-00008
• Device Sequence Number: 9082754
• Product Code: GEX
• UDI-Device Identifier: 00813125015220
• UDI-Public: 00813125015220
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K143154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 200322
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown