MAUDE Adverse Event Report: IRIDEX CORPORATION G PROBE ILLUMINATE

Model Number	16200
Medical Device Problem Code	Output above Specifications (1432)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident is not deemed to be a serious incident due to: 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.Therefore, because conjunctival burns are a known risk associated with the delivery of laser energy, and because conjunctival burns typically resolve within 24 to 48 hours without any medical intervention, it is determined that this event is deemed not a serious incident.Iridex will query the physician for additional clinical information.If additional information indicates a burn occurred that required medical intervention and/or permanently impaired a body structure, iridex will reconsider this reporting determination.
Event or Problem Description
It was reported that a patient experienced a conjuctival burn after 10 impacts with a g probe illuminate rfid.

• Brand Name: G PROBE ILLUMINATE
• Common Device Name: G PROBE ILLUMINATE
• Manufacturer (Section D): 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: 23483065
• Report Number: 2939653-2025-00007
• Device Sequence Number: 9478545
• Product Code: GEX
• UDI-Device Identifier: 00813125015701
• UDI-Public: 00813125015701
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2025

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
• Device Model Number: 16200
• Device Lot Number: 901355
• 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: 07/25/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2025
• 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 Sex: Unknown