MAUDE Adverse Event Report: IRIDEX CORPORATION G-PROBE RFID

Lot Number	900774
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	03/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Iridex became aware of an incident that during a ciliary body photocoagulation procedure, the patient's sclera coagulated when using the g-probe delivery device.The treatment was being performed along with the cyclo g6 laser console.The complainant specifically mentioned that the tip of the g-probe was different from that of the normal product.A replacement probe was used, and procedure was completed with no further complications.This event is a known failure mode based on functional design features and may require intervention.

• 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: 23840279
• Report Number: 2939653-2024-00036
• Device Sequence Number: 15852758
• Product Code: GEX
• UDI-Device Identifier: 00813125015220
• UDI-Public: 00813125015220
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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
• Device Lot Number: 900774
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 12/18/2025
• 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 Age: 48 YR
• Patient Sex: Female