MAUDE Adverse Event Report: IRIDEX CORPORATION IRIDEX OCULIGHT TX

Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	12/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Iridex became aware of an incident involving oculight tx laser console and slit lamp adapter (sla) were the laser output was too high and caused bleeding at patient's eye.The treatment setting and technique used during the procedure was set to 200mw.The patient did not have any significant medical history.The patient was unaware of the bleeding and the doctor immediately stopped the treatment upon realizing there was a minor bleed.The patient was given an eyedrop after the procedure and did not report any further complications.The unit was not returned for evaluation, however upon service investigation it was determined that the issue was caused by a burnt fiber.Fiber replacement was sent to the customer.The reported event due to a burnt fiber is a known risk/failure mode.The oculight tx console operator manual clearly instructs on the physician verify that the fiber-optic connector is not damaged before use as well as the pre-set parameter settings beginning at low power with short duration exposures, the surgeon should note the surgical effect and increase power, power density, or exposure duration until the desired surgical effect is obtained.The operative needs of each patient should be individually evaluated based on the indication, treatment location, and on the patient's medical and wound healing history.If uncertain of expected clinical response, always start with a conservative setting and increase the setting in small steps.

• Brand Name: IRIDEX OCULIGHT TX
• Common Device Name: IRIDEX OCULIGHT TX
• 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: 23830744
• Report Number: 2939653-2023-00023
• Device Sequence Number: 20091594
• Product Code: GEX
• UDI-Device Identifier: 00813125016494
• UDI-Public: 00813125016494
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K062369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown