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

Model Number	15522
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Engineering failure analysis was not performed at the time of this report as the probe is yet to be returned for evaluation.Once the probe is returned and the results of the failure analysis is received with new information, a follow up supplemental report will be submitted.At this time, it is not possible to determine the root cause of the issue.It is suspected that the most likely cause of the adverse event was possibly due to overpowering the device, however treatment settings used was within the normal setting parameters.Iridex will investigate the event and an amended report will be submitted if additional information becomes available and investigation results are provided.The cyclo g6 laser console operator manual operator manual clearly instructs on the pre-set parameter settings based on the needs of each patient and should be individually evaluated based on the indication, treatment location, and on the patient's medical and wound healing history.Per the operating manual, setting should begin with low power with short duration exposures, the surgeon should note the surgical effect and increase power, power density, or exposure duration until the desired surgical effect is obtained.It is suggested that treatment setting always start with a conservative setting and to increase setting in small steps.Treatment setting parameters for mp3 probe are as follows: power mw (2000-2250) with exposure duration of 50,000-180,000 superior with total energy of 31-126.The ifu also provides stepwise directions for proper probe tip placement and sweeping motion to avoid excessively focused power.The ifu provides recommended laser console power and duty cycle settings based on use by experienced clinicians.
Event or Problem Description
Iridex became aware of a patient incident that occurred at valley laser and surgery center involving an iridex micropulse p3 device.It was reported that the mp3 device had popped and charred at the end of the probe during a patient procedure.The patient was given an anesthesia and was under mild sedation.There was no reported patient impact or adverse effects as a result of the incident.It is unknown if the patient had any underlying conditions or disease states at the time of the incident.No other patient information was provided.The procedure was completed with no other reported injuries or complications.

• 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 1305
• Manufacturer Contact: rudolph dizon ; 1212 terra bella avenue; mountain view, CA 94043-1824
• MDR Report Key: 21337602
• Report Number: 2939653-2025-00001
• Device Sequence Number: 3826663
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 15522
• Device Lot Number: 801250
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 02/07/2025
• 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
• Patient Age: 82 YR
• Patient Sex: Unknown