MAUDE Adverse Event Report: IRDEX CORPORATION MICROPULSE P3 PROBE; MP3

Lot 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	07/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to iridex that while using the micropulse p3 probe (mp3), the patient experienced conjunctival burn.The reported settings used for treatment were consistent with the mp3 ifu (2500 mw for 3.4 seconds with an interval of 20 seconds).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.Conjunctival burns are a known potential harm associated with the use of laser delivery in ophthalmic indications.Typically, conjunctival 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 conjunctival 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.The laser console used with the probe was the cyclo g6 laser console.The laser console was returned to iridex for further investigation.As per the investigation, no problem was found with the console and it was returned to the customer.
Additional Manufacturer Narrative
Feedback from customer: "the conjunctival burn that occurred was minor; the area healed spontaneously, without intervention, within several days.There was no residual damage that remained.The patient's vision has been limited due to longstanding exudative macular degeneration and severe glaucoma.The ae that occurred is unlikely to have affected the patient's vision and has resolved completely.".

• Brand Name: MICROPULSE P3 PROBE
• Common Device Name: MP3
• Manufacturer (Section D): IRDEX CORPORATION; 1212 terra bella avenue; mountain view CA 94043 1824
• Manufacturer (Section G): IRIDEX CORPORATION; 1212 terra bella aveune; mountain view CA 94043 1824
• Manufacturer Contact: bill hyatt ; 1212 terra bella avenue; mountain view, CA 94043-1824 ; 6506058727
• MDR Report Key: 23791068
• Report Number: 2939653-2025-00003
• Device Sequence Number: 17535470
• Product Code: GEX
• UDI-Device Identifier: 00813125016647
• UDI-Public: 00813125016647
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

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
• Device Lot Number: 15522
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 12/12/2025
• 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: Female
• Patient Ethnicity: Non Hispanic