MAUDE Adverse Event Report: IRIDEX CORPORATION G-PROBE RFID

Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	11/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Iridex became aware of a patient incident during a medical procedure resulting in a conjunctival burn.The procedure was performed using iridex g-probe and iridex cyclo g6 laser console.The reported procedure employed higher power settings: 2500 mw with 1000 ms per sweep with 5 sweeps per quadrant which 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.Since the parameters used are out of specification, it potentially resulted in increasing the risk of tissue damage and conjunctival burn.This deviation from recommended parameters, combined with possible probe contamination, may have contributed to the adverse outcome.Probe was discarded post procedure.There were no other complications or injuries reported.No problems with the laser console was reported.Conjunctival burn is a known potential issue with the delivery of laser energy.There was no report of any permanent impairment to the patient, and 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 94043 1824
• Manufacturer Contact: bill hyatt ; 1212 terra bella avenue; mountain view, CA 94043-1824 ; 6506058727
• MDR Report Key: 23699043
• Report Number: 2939653-2024-00040
• Device Sequence Number: 21426483
• Product Code: GEX
• UDI-Device Identifier: 00813125015237
• UDI-Public: 00813125015237
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 12/02/2025
• 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: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American