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	Eye Injury (1845)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to iridex that a conjunctival tear occurred while treating a patient but the tear was minor and it happened at the end of the treatment.This is a predicted complication associated with the use of any ophthalmic laser system when used to deliver treatment.No information regarding the patient, patient recovery, treatment parameters used were provided to iridex to have a conclusive finding.In accordance with standard protocol, iridex will proceed with processing the complaint based on the information currently available.Taking a proactive approach, iridex reviewed ifu guidance for scenarios where the g-probe might contribute to conjunctival tearing.The ifu advises: 1.Keep the probe tip and eye surface moist throughout the procedure.2.If the device snags on the conjunctiva, momentarily stop laser treatment, release the conjunctiva, reposition the device, and then resume treatment.Typically, conjunctival tears 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 conjunctival 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.

• 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 94943 1824
• Manufacturer Contact: bill hyatt ; 1212 terra bella avenue; mountain view, CA 94043-1824 ; 6506058727
• MDR Report Key: 23891131
• Report Number: 2939652-2024-00038
• Device Sequence Number: 7707795
• Product Code: GEX
• UDI-Device Identifier: 00813125015237
• UDI-Public: 00813125015237
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/24/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 12/24/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown