MAUDE Adverse Event Report: IRIDEX CORPORATION G-PROBE RFID

Model Number	UNKNOWN
Medical Device Problem Code	Output above Specifications (1432)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	07/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Iridex became aware of this incident through published scientific literature.Transscleral cyclophotocoagulation (tcp) was performed using an iridex g-probe delivery device with the iridex cyclo g6 laser console.During treatment, conjunctival burns and scleral perforation occurred leading to termination of the procedure.Medical intervention was required to address the scleral perforation and included a patch graft using split-thickness donor cornea.Because there was no report of probe or laser console malfunction, the laser settings (number of applications and treatment parameters) were reviewed to determine if the event was related to laser settings: · number of applications: 9 treatment spots were applied before the perforation occurred (initial at 2100 mw, five spots at 2050 mw, then three spots at 1500 mw).· treatment parameters: all applications were performed at 4-second duration with power levels up to 2050 mw.The user applied at least 30% more laser energy than the iridex recommended treatment parameters given the duration used.The iridex recommended treatment parameters are: 1.For dark brown eyes: 1250 mw for 4 seconds.2.For all other eyes: 1500 mw for 3.5 seconds.The iridex ifu recommends parameters to be used with "slow coagulation" technique.However, it appears that the user used slow coagulation technique (as described in the ifu); but the user used power and duration settings consistent with a different technique (gaasterland technique).It seems likely that the use of higher power combined with the classic slow coagulation technique duration directly led to the perforation incident.Therefore, the perforation event is most likely due to the use of power and duration settings inconsistent with iridex recommended parameters.
Additional Manufacturer Narrative
Patient had a history of primary open-angle glaucoma (poag) and underwent bilateral extracapsular cataract extraction with posterior chamber intraocular lens implantation over 20 years ago.She experienced sudden, profound vision loss in the left eye two years ago due to a stroke.Systemic history included breast cancer and hypertension, with no autoimmune conditions.Pre-procedure exam showed low visual acuity in both eyes, trace conjunctival injection without pigmentation or hemorrhage, no scleral thinning, clear cornea, and no anterior chamber cells.The right eye had 90% optic nerve cupping with a pink rim, and the left eye had almost total cupping with a pale rim.

• 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: 23589336
• Report Number: 2939653-2024-00021
• Device Sequence Number: 15767889
• Product Code: GEX
• UDI-Device Identifier: 00813125015237
• UDI-Public: 00813125015237
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Literature
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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 Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• 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: 05/24/2024
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female