MAUDE Adverse Event Report: IRIDEX CORPORATION MICROPULSE P3 DEVICE; MP3 PROBE

Lot Number	801158
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient burn incident that occurred at dupont surgery center was reported to iridex on (b)(6) 2024.The procedure was performed using the cyclo g6 laser console with iridex micropulse p3 probe (mp3).The cyclo g6 laser console was returned to iridex for investigation but no problem was found with the laser console during mfg tested process.Issue was related to probe and not unit.Probe was not returned to iridex.Typically probes not serviced by iridex and are considered biohazardous once used.It is recommended to discard them post treatment on a patient.Three follow-up emails were sent to the customer requesting additional information regarding the reported patient burn: however, no response wasreceived.In accordance with standard protocol, iridex will proceed with processing the complaint based on the information currently available.Ophthalmic laser systems are intended to deliver thermal (laser) energy to deliver an insult (burn) to the ciliary body.Conjunctival burns are a known and predicted complication associated with the use of any ophthalmic laser system (console and delivery device) when used to deliver transscleral treatment.It is listed in both the ifu included in mp3 delivery device as well as within the cyclo g6 laser operating manual.No other treatment parameters were shared with iridex to reach a conclusive investigation finding of the reported patient burn.
Additional Manufacturer Narrative
Conjunctival burns 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: MICROPULSE P3 DEVICE
• Common Device Name: MP3 PROBE
• 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: 23744566
• Report Number: 2939653-2024-00032
• Device Sequence Number: 10464194
• Product Code: GEX
• UDI-Device Identifier: 00813125015244
• UDI-Public: 00813125015244
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 12/08/2025

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: 801158
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 12/08/2025
• 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