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

Model Number	15522
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Conjunctival Hemorrhage (4808)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient experienced a subconjunctival hemorrhage during treatment with the micropulse p3 probe delivery device.No further information regarding this adverse event is available.The adverse event is being investigated by iridex.

• Brand Name: MICROPULSE P3 PROBE
• 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 1824
• Manufacturer Contact: nimrta tandan ; 1212 terra bella ave; mountain view, CA 94043-1824
• MDR Report Key: 19538669
• Report Number: 2939653-2024-00012
• Device Sequence Number: 20353832
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/06/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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