MAUDE Adverse Event Report: Iridex Corporation MicroPulse P3 Probe

Model Number	15522
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	08/31/2026
Type of Reportable Event	Serious Injury

• Brand Name: MicroPulse P3 Probe
• Common Device Name: MicroPulse P3
• Manufacturer (Section D): Iridex Corporation; 1212 terra bella ave; mountain view CA 94043 -182
• Manufacturer (Section G): Iridex Corporation; 1212 terra bella avenue; mountain view CA 94043 -182
• Manufacturer Contact: hussam al-alsarag ; 212 terra bella avenue,; mountain view, CA 94043--182 ; +1(650)605-8727
• MDR Report Key: 50941362
• Report Number: 2939653-2026-00020
• Device Sequence Number: 10739896
• Product Code: GEX
• UDI-Device Identifier: 00813125015244
• UDI-Public: 00813125015244
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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 Model Number: 15522
• Device Lot Number: 880015
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/31/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Race: Black Or African American