MAUDE Adverse Event Report: ALMA LASERS LTD. OPUS SYSTEM; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE

Model Number	1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Eye Pain (4467)
Date of Event	04/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported that a patient experienced eye pain and blurred vision approximately thirty minutes after leaving the facility, where she had undergone treatment with the opus system.According to the report, the patient subsequently visited an emergency department and was treated with eye drops, which resolved her symptoms within 48 hours.No diagnostic information was provided by the attending ophthalmologist; therefore, a direct causal relationship between the reported symptoms and the opus system could not be established.Nonetheless, this report is being submitted in good faith.

• Brand Name: OPUS SYSTEM
• Common Device Name: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE
• Manufacturer (Section D): ALMA LASERS LTD.; 18 haharash street; north industrial park, caesarea 30798 95; IS 3079895
• MDR Report Key: 22484489
• Report Number: 3004450661-2025-00016
• Device Sequence Number: 15578159
• Product Code: GEI
• UDI-Device Identifier: 17290110121782
• UDI-Public: 17290110121782
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2025
• Report Date (Section F): 07/11/2025

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
• Device Model Number: 1
• Device Catalogue Number: AASP12091701BA0001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 5 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/10/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Female
• Date Report Sent to FDA: 07/11/2025