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 Codes	Eye Injury (1845); Eye Burn (2523)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following sections in this report is incompleted due to the limited information of the adverse event that was reported to iridex: section a: patient information.Section e: initial reporter.Iridex is currently investigating the complaint and has reached out to the complainant to gather more information of the reported adverse event.
Event or Problem Description
An adverse event was reported to iridex of a patient experiencing conjunctival burns while being treated with the micropulse p3 probe delivery device and the cyclo g6 laser system.It was reported that a probe malfunction caused the conjunctival burns.The user switched to a new probe and was able to complete the procedure without further incident reported.No other additional information was provided to iridex about the adverse event, including the specific device malfunction was not reported.Given the limited information reported to iridex it is currently unknown how device performance may have caused or contributed to the conjunctival burns.Iridex is currently investigating the complaint and has contacted the complainant to gather more information.

• Brand Name: MICROPULSE P3 DEVICE
• Common Device Name: MP3 PROBE
• Manufacturer (Section D): IRIDEX CORPORATION; 1212 terra bella ave; mountain view CA 94043 1824
• Manufacturer (Section G): IRIDEX CORPORATION; 1212 terra bella ave; mountain view CA 94043 9149
• Manufacturer Contact: nimrta tandan ; 1212 terra bella ave; mountain view 94043-9149
• MDR Report Key: 19534141
• Report Number: 2939653-2024-00014
• Device Sequence Number: 20917120
• Product Code: GEX
• UDI-Device Identifier: 00813125015251
• UDI-Public: 00813125015251
• Combination Product (Y/N): N
• 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: Other
• 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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 06/13/2024
• 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