MAUDE Adverse Event Report: IRIDEX CORPORATION G-PROBE RFID

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Choroidal effusion (4878)
Date of Event	06/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent laser cyclophotocoagulation using the g-probe with the cyclo g6 console for the management of medically refractory glaucoma.Following the procedure, the patient developed choroidal effusions.The patient had no history of anticoagulant use, diabetes, or other systemic disease.Postoperatively, the patient developed choroidal effusions and hypotony, with a decline in vision.No conjunctival hemorrhage, bleeding, pigmented lesions, or dark areas were noted during or after the procedure.No device malfunctions were noted during the procedure.The device was returned for servicing but no issues were found.The treatment parameters used were consistent with the g-probe ifu recommendations: power of 1500 mw, duration of 3500 ms per application, and a total of 15 treatment spots.The device functioned as intended throughout the procedure, and no alarms or malfunctions were reported.The event is not device related, there was no device malfunction reported.Hypotony with effusions and hemorrhage after g-probe cases can happen with diseased eyes that are at the end of their treatment paradigm.It is most likely that the choroidal effusions are due to a combination of the patient's age and glaucoma severity and not due to device performance.Eyes with severe, end-stage glaucoma are at higher risk for postoperative hypotony and effusions due to fragility.

• 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: 23783250
• Report Number: 2939653-2024-00022
• Device Sequence Number: 17400959
• Product Code: GEX
• UDI-Device Identifier: 00813125015237
• UDI-Public: 00813125015237
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2025

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
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Female