MAUDE Adverse Event Report: IRIDEX CORPORATION G-PROBE RFID

Model Number	15980
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	04/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Typically, 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.
Event or Problem Description
It was reported to iridex that while using the g-probe rfid laser delivery device, the patient experienced conjunctival burn.No permanent impairment was reported to iridex, and no medical intervention associated with the burn was reported to iridex.Replacement g-probes are being sent to the customer.The defective probe is not available at the customer and won't be returned to iridex.Additionally, it should be noted that probes are not serviced by iridex since they are single use and if the probes are used during treatment, it is recommended to dispose them as they become biohazard.No issues regarding the laser console being used during the treatment were reported to iridex.The reported settings used for treatment were consistent with the ifu (40-second passes per hemisphere; power: 1250 mv).No permanent impairment was reported to iridex, and no medical intervention associated with the burn was reported to iridex.As per the ifu, following are the recommendations for treatment purpose - "keep the g-probe tip clean to minimize the risk of burns to the ocular surface.If the tip becomes dirty during the procedure, clean it gently with an alcohol swab.If a scleral burn occurs, discontinue use and replace the g-probe immediately.The g-probe is a single-use product.Contamination of the fiber optic tip by blood or tissue char may result in ocular surface burns." the instructions for use (ifu) warn users that contamination of the fiber optic tip by blood or tissue char may result in ocular surface burns.Since this risk is already identified in the ifu, and laser treatment inherently involves the application of heat to eye tissue, scleral burns are expected side effects of laser treatment.While the event is not classified as serious because scleral burns typically resolve on their own within 24 to 48 hours, iridex will nonetheless proceed with reporting this event to the fda.

• 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: 24987270
• Report Number: 2939653-2026-00007
• Device Sequence Number: 9535612
• Product Code: GEX
• UDI-Device Identifier: 00813125015237
• UDI-Public: 00813125015237
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/24/2026

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
• Device Model Number: 15980
• Device Lot Number: 200359
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Race: Black Or African American