MAUDE Adverse Event Report: ALMA LASERS LTD OPUS

Catalog Number	AASP12091701BA0001
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
The importer reported that 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.
Additional Manufacturer Narrative
The importer reported that 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
• Common Device Name: OPUS
• Manufacturer (Section D): ALMA LASERS LTD; 18 haharash street; north industrial park; 30798 95; IS 3079895
• Manufacturer (Section G): ALMA LASERS, LTD; 18 haharash street; north industrial park; caesarea, 30798 95; IS 3079895
• Manufacturer Contact: odelia zerbiv ; 18 haharash street; north industrial park; caesarea, 30798-95 ; IS 3079895
• MDR Report Key: 22748655
• Report Number: 3004167969-2025-00016
• Device Sequence Number: 13151074
• Product Code: GEI
• UDI-Device Identifier: 17290110121782
• UDI-Public: (01)17290110121782(11)20200730
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2025

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 Catalogue Number: AASP12091701BA0001
• 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: 07/10/2025
• Initial Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2020
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Female