MAUDE Adverse Event Report: IRIDEX CORPORATION OCULIGHT SLX TRI-MODE CONSOLE 115V

Model Number	13030-220
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	11/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient experienced an injury while being treated with iridex oculight slx laser system.The probe was discarded.No other information was provided on the reported adverse event.It is unknown if the device malfunctioned.Therefore, given to the limited information it is unknown whether the device performance may have led to the patient injury.Iridex is currently investigating this adverse event and has contacted the complainant to gather more information.

• Brand Name: OCULIGHT SLX TRI-MODE CONSOLE 115V
• Common Device Name: OCULIGHT SLX
• Manufacturer (Section D): IRIDEX CORPORATION; 1212 terra bella ave; mountain view CA 94043 9149
• Manufacturer (Section G): IRIDEX CORPORATION; 1212 terra bella ave; mountain view CA 94043 9149
• Manufacturer Contact: nimrta tandan ; 1212 terra bella ave; mountain view, CA 94043-9149
• MDR Report Key: 19538827
• Report Number: 2939653-2024-00008
• Device Sequence Number: 12282213
• Product Code: GEX
• UDI-Device Identifier: 00813125016289
• UDI-Public: 00813125016289
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K020374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2024

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: 13030-220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (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