MAUDE Adverse Event Report: IRIDEX CORPORATION MICROPULSE P3 DEVICE

Model Number	15522
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Typically, 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.
Event or Problem Description
It was reported to iridex that while using the micropulse p3 probe (mp3 probe), the patient experienced conjunctival burn.The reported settings used for treatment were consistent with the ifu recommendation of four 20-second passes per hemisphere; power: 2500 mv.No permanent impairment was reported to iridex, and no medical intervention associated with the burn was reported to iridex.The probe, which is disposable, was not returned to iridex for further investigation.Also, probes are not serviced by iridex since they are single use and if the probes are used during treatment, it is recommended to dispose them as they become biohazard.Also, it was reported that the probe tip was burned.As per the ifu, the user is informed to inspect the probe footplate for debris or "charring" and confirm gel is adequately present after the treatment of a hemisphere.If the probe tip accumulates debris or "charring" during the procedure, the user is instructed to clean it gently with sterile gauze and a saline solution.The device tip needs to be kept clean to minimize the risk of burns to the ocular surface.After cleaning the tip, the user is required to re-apply a drop of methylcellulose gel and continue treatment.If the "charring" or discoloration on the tip cannot be removed by gentle cleaning, it is recommended to discard the device.Scleral burns are not typical and may indicate contamination at the device tip.If a scleral burn occurs, discontinue use and replace the device immediately.Because conjunctival burns are a known risk associated with the delivery of laser energy, and because conjunctival burns typically resolve within 24 to 48 hours without any medical intervention, it is determined that this event is deemed not a serious incident.

• Brand Name: MICROPULSE P3 DEVICE
• Common Device Name: MICROPULSE P3 DEVICE
• 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: 24942460
• Report Number: 2939653-2026-00005
• Device Sequence Number: 5651085
• Product Code: GEX
• UDI-Device Identifier: 00813125016647
• UDI-Public: 00813125016647
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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: 801460
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/21/2026
• 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: 74 YR
• Patient Sex: Female