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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 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
A patient incident occurred involving an iridex micropulse p3 (mp3) device that caused smoking and bubbling resulting in a conjunctival burn.The laser console used with the probe was iridex cyclo g6 laser console.The mp3 probe discarded.The cyclo g6 device was not returned for investigation.Conjunctival burns are a well-known potential complication associated with the micropulse treatment.It is listed in both the ifu for the mp3 delivery device as well as ifu for the cyclo g6 laser operating manual.The severity of this complication is considered relatively low and usually resolves without intervention within 24-48 hours.During the incident, the settings used by the physician were that each sweep lasted about 15 seconds, with a total of five sweeps per quadrant.Laser power was set at 2500 mw, and the duty cycle was maintained at 31.3% (0.5 ms on / 1.1 ms off).These settings fall within the iridex ifu recommended range of 2000-2500 mw, 10-20 seconds per sweep, and 3-5 passes per quadrant, positioning the treatment at the upper end of the recommended spectrum.As per the ifu, best practices to be considered to reduce the occurrence of conjunctival burns - 1.Avoid treating areas with conjunctival/scleral pigmentation, hyperemia, hemorrhage, marking ink, or betadine, as these can absorb 810 nm light and increase burn risk.2.Always use and frequently reapply a viscous, transparent coupling agent to ensure proper energy transfer and reduce burn risk.3.Apply only light contact with the probe; avoid excessive pressure to prevent tissue damage and minimize burn risk.This does not reflect the device failure or usage failure, rather the incident reflects a known possible complication likely related to one or more of the first three factors outlined above, which may not have been optimal during treatment.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.The ifu contains directions stating the following guidelines: "after treatment of a hemisphere, inspect the probe footplate for debris or "charring" and confirm gel is adequately present.If the probe tip accumulates debris or "charring" during the procedure, clean it gently with sterile gauze and a saline solution.Keep the device tip clean to minimize the risk of burns to the ocular surface.After cleaning the tip, re-apply a drop of re-apply a drop methylcellulose gel and continue treatment.If the "charring" or discoloration on the tip cannot be removed by gentle cleaning, 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.".

• 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 Contact: bill hyatt ; 1212 terra bella avenue; mountain view, CA 94043-1824 ; 6506058727
• MDR Report Key: 23707219
• Report Number: 2939653-2024-00037
• Device Sequence Number: 16109280
• Product Code: GEX
• UDI-Device Identifier: 00813125016647
• UDI-Public: 00813125016647
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 12/03/2025

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: 08/27/2024
• Initial Report FDA Received Date: 12/03/2025
• 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: 73 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American