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	12/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Iridex became aware of a patient that experienced a conjunctival burn during treatment with the micropulse p3 probe delivery device.There is no additional information regarding the reported adverse event.There was no record of the complainant or reporter information.It is unknown if the event was caused by a user or device related.Device was not returned to iridex for further investigation.No treatment parameters or patient related information was shared to reach a conclusive finding.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 comnplication 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.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: 23884116
• Report Number: 2939653-2024-00034
• Device Sequence Number: 4669846
• Product Code: GEX
• UDI-Device Identifier: 00813125015251
• UDI-Public: 00813125015251
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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: Other
• Patient Sex: Unknown