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

Lot Number	801328
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	01/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to iridex that while using the micropulse p3 delivery device (mp3 probe) along with cyclo g6 laser console, the patient experienced conjunctival burn.Iridex mp3 probes are sterile, single use delivery devices and are recommended to be discarded post use per the operator manual.Neither the mp3 probe nor the cyclo g6 laser console was not returned to iridex for further investigation in this case.Conjunctival burns are a known potential harm associated with the use of laser delivery in ophthalmic indications.Per the complaint received, the probe tip was charred.Ophthalmic laser systems are intended to deliver thermal (laser) energy to deliver an insult (burn) to the ciliary body.The most likely cause of the reported adverse event is suspected to be contamination (e.G., blood, tissue or betadine) on the probe tip when the laser was activated.It should be noted that the instructions for use (ifu) cautions the user to "inspect the probe footplate for debris or 'charring' and confirm gel is adequately present" and if a "burn occurs, discontinue use and replace the device immediately." typically, conjunctival burns resolve within 24 to 48 hours.Therefore, unless either medical intervention or permanent impairment are reported, conjunctival burns are not deemed a serious adverse event, because conjunctival burns typically: 1 do not result in life-threatening illness or injury, 2 do not result in permanent impairment of a body structure or a body function, 3 do not require hospitalization or prolongation of patient hospitalization, 4 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 DELIVERY 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
• MDR Report Key: 24397187
• Report Number: 2939653-2026-00002
• Device Sequence Number: 18206330
• Product Code: GEX
• UDI-Device Identifier: 00813125016647
• UDI-Public: 00813125016647
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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: 801328
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 02/19/2026
• 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