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

Lot Number	801010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	06/07/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported to iridex that while using the micropulse p3 probe, a physician noticed smoke coming out of the probe tip and the physician noticed conjunctival burn.Device was not returned to iridex for further investigation.Ophthalmic laser systems are intended to deliver thermal (laser) energy to deliver an insult (burn) to the ciliary body.Conjunctival burns are a known and predicted complication associated with the use of any ophthalmic laser system (console and delivery device) when used to deliver transscleral treatment.It is listed as a possible comnplication in the ifu for mp3 delivery device.Conjunctival burns are a specific type of ocular burn that can occur along with corneal burns, often due to chemical or thermal injury and are typically superficial, posing no long-term threat to the patient.Typically, these burns resolve within 24-48 hours post op without additional intervention.Iridex corporation does report every adverse event via the fda's manufacturer and user facility device experience (maude) database.The treatment parameters reported (1500 mw power, 1500 ms per sweep, 5 sweeps per quadrant) differ significantly from the parameters suggested in the mp3 ifu (2000-2500 mw power, 10-20 seconds per sweep, 3-5 passes per quadrant).Specifically, the physician used a substantially lower power setting and much shorter sweep duration, resulting in significantly less total treatment energy delivered to the eye.The physician adhered to the procedural approach (number of sweeps and quadrant coverage) but selected conservative energy settings.The physician changed the probe being used and there was no further issue during the 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.Contamination of the fiber optic tip by blood or tissue char may result in ocular surface burns and a smoking tip of the probe.

• 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 1824
• Manufacturer Contact: bill hyatt ; 1212 terra bella avenue; mountain view, CA 94043-1824 ; 6506058727
• MDR Report Key: 23770008
• Report Number: 2939653-2024-00030
• Device Sequence Number: 18579550
• Product Code: GEX
• UDI-Device Identifier: 00813125015251
• UDI-Public: 00813125015251
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2025

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: 801010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 12/10/2025
• 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: 58 YR
• Patient Sex: Male