MAUDE Adverse Event Report: IRIDEX CORPORATION PASCAL SYNTHESIS 577

Model Number	SA-06285
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, iridex became aware of an incident that occurred at the mass eye & ear infirmary that involved a pascal synthesis ophthalmic laser system, which is a laser system integrated with a table.It was reported that while attempting to move the table when the laser was not in use, the support for one of the table legs was compromised and the table fell.It should be noted that the table fall occurred when the product was not in use and is unrelated to the delivery of laser energy.The initial report did not indicate that the table fall resulted in an injury.In subsequent follow up communications with the site, it was learned that the table fell on an employee's foot resulting in employee injury, specifically a fractured right hallux.No patient was present, the laser system was not in use at the time of the event, and the product was in transit from the property's storage room.In a review of product records, it was determined that the event occurred on an 8-year-old product that was beyond product warranty.

• Brand Name: PASCAL SYNTHESIS 577
• Common Device Name: PASCAL SYNTHESIS
• Manufacturer (Section D): IRIDEX CORPORATION; 1212 terra bella avenue; mountain view 94043 1824
• Manufacturer (Section G): IRIDEX CORPORATION; 1212 terra bella avenue; mountain view CA 94043 1824
• Manufacturer Contact: rudolph dizon ; 1212 terra bella avenue; mountain view, CA 94043-1824
• MDR Report Key: 22029782
• Report Number: 2939653-2025-00004
• Device Sequence Number: 20959720
• Product Code: HQF
• UDI-Device Identifier: 00813125015534
• UDI-Public: 00813125015534
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K223132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2025

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?: Yes
• Operator of Device: Other
• Device Model Number: SA-06285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2017
• 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; Required Intervention
• Patient Sex: Female