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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	03/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Iridex became aware of a patient incident involving a conjunctival burn reported by physician surgery center of albuquerque using a micropulse p3 probe and cyclo g6 laser console.Cyclo g6 laser console returned to iridex for servicing.During technical inspection, the console passed visual inspection and rfid jumper fiber detection.No error codes indicating malfunction were displayed.The laser console also passed the power requirements, and no anomalies were observed.Probes not returned to iridex for technical inspection.Probes not serviced by iridex and are considered biohazardous once used.It is recommended to discard them post treatment on a patient.Conjunctival burns are a known potential harm associated with the use of laser delivery in ophthalmic indications.Possibility of conjunctival burn are listed in both the ifu included in mp3 delivery device as well as within the cyclo g6 laser operating manual due to heating up the tip of the probe used to delivery the laser power.The procedure was performed using a treatment setting of 2250 mw with an exposure time of 15-20 seconds per hemisphere, applying 4-5 sweeps.These parameters fall within the range suggested in the mp3 ifu, which recommends 2000-2500 mw power, 10-20 seconds per sweep, and 3-5 passes per quadrant.Intraoperatively, there was no sub-conjunctival hemorrhage or bleeding observed in the surgical field.Post-procedure, betadine solution was administered, and the patient reported no further complications.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.
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.

• Brand Name: MICROPULSE P3 DEVICE
• Common Device Name: MP3
• 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: 23818842
• Report Number: 2939653-2024-00027
• Device Sequence Number: 9295264
• Product Code: GEX
• UDI-Device Identifier: 00813125015251
• UDI-Public: 00813125015251
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2025

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: 04/15/2024
• Initial Report FDA Received Date: 12/16/2025
• 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 Age: 66 YR
• Patient Sex: Male