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	07/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Iridex was notified of a patient experiencing macular edema during a procedure using micropulse p3 probe (mp3 probe).The condition caused temporary visual disturbance but resolved without additional treatment.The doctor indicated it was likely a known complication of the procedure, not a device malfunction.Device was not returned to iridex for further investigation.Iridex takes proactive approach in notifying fda regarding any adverse events and hence a medwatch (3500a) form is being submitted for this adverse event.

• 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: 23831832
• Report Number: 2939653-2023-00021
• Device Sequence Number: 4992930
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 12/17/2025
• 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