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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	03/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conjunctival/scleral 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 scleral 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.
Event or Problem Description
On (b)(6) 2024, during a transscleral laser treatment for glaucoma using iridex micropulse p3 probe, the patient sustained a conjunctival burn.The physician immediately stopped the procedure, replaced the probe, and completed the treatment without further complications.The physician suspected the initial probe was defective.Device was not returned to iridex for further investigation.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 as a possible complication in the ifu for mp3 delivery device.Conjunctival burns are a specific type of ocular burn that can occur along with corneal burns, often due to chemical or thermal injury and are typically superficial, posing no long-term threat to the patient.Typically, these burns resolve within 24-48 hours post op without additional intervention.Iridex corporation does report every adverse event via the fda's manufacturer and user facility device experience (maude) database.Power settings used was 2500 mw with micropulse setting.Patient did not have any significant medical history.The physician adhered to the procedural approach as recommended in the mp3 probe ifu.Procedure was able to be completed without further issue.Patient was seen the following week and was recovering well with injury mostly resolved.Another factor to be taken into account is that occasionally, the tip of the probe will become contaminated with blood or tissue, and the contaminants on the tip can become hated when exposed to laser energy.Contamination of the fiber optic tip by blood or tissue char may result in ocular surface burns and a smoking tip of the probe.

• 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: 23774011
• Report Number: 2939653-2024-00029
• Device Sequence Number: 15833030
• Product Code: GEX
• UDI-Device Identifier: 00813125015251
• UDI-Public: 00813125015251
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/10/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 12/10/2025
• 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