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

Model Number	15522
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Due to the limited information it is unknown whether the device performance may have led to the patient injury.Iridex is currently investigating the complaint and will reach out to the complainant to gather more information of the reported adverse event.
Event or Problem Description
It was reported to iridex that a patient sneezed and experienced a slight conjunctival tear during treatment with the micropulse p3 delivery device.No other information was provided to iridex regarding the adverse event.Due to the limited information it is unknown whether the device performance may have led to the patient injury.Iridex is currently investigating the complaint and will reach out to the complainant to gather more information of the reported adverse event.

• Brand Name: MICROPULSE P3 DEVICE
• Common Device Name: MP3 PROBE
• Manufacturer (Section D): IRIDEX CORPORATION; 1212 terra bella ave; mountain view CA 94043
• Manufacturer (Section G): IRIDEX CORPORATION; 1212 terra bella ave; mountain view CA 94043
• Manufacturer Contact: nimrta tandan ; 1212 terra bella ave; mountain view, CA 94043
• MDR Report Key: 19541668
• Report Number: 2939653-2024-00017
• Device Sequence Number: 7549985
• Product Code: GEX
• UDI-Device Identifier: 00813125015251
• UDI-Public: 00813125015251
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2024

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: 80100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 06/14/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown