MAUDE Adverse Event Report: BELKIN VISION EAGLE DEVICE; LASER, OPHTHALMIC

Catalog Number	430840010
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that during an direct selective laser trabeculoplasty treatment system has shut down twice without user input and the procedure was aborted.The doctor did not do a retreat after it was aborted not even half.The system was calibrated and yes it was successful.It aborted during a treatment.
Additional Manufacturer Narrative
Additional information was added in h.3., h.6.And h.11.The company representative was unable to confirm nor replicate the reported event.The system was then tested and found to meet specification.A non-conformance based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation with the same event code.The system was found to meet specifications.Therefore, the root cause of the reported event is inconclusive.The manufacturer internal reference number is: (b)(4).

• Brand Name: EAGLE DEVICE
• Common Device Name: LASER, OPHTHALMIC
• Manufacturer (Section D): BELKIN VISION; 13 gan raveh st; pob 13254; yavne 81222 14; IS 8122214
• Manufacturer (Section G): BELKIN VISION; 13 gan raveh st; pob 13254; yavne 81222 14; IS 8122214
• Manufacturer Contact: tamar weizman ; 13 gan rave blvd; yavne 81222-14 ; IS 8122214 ; 0547999997
• MDR Report Key: 22141017
• Report Number: 3027683457-2025-00012
• Device Sequence Number: 7023211
• Product Code: HQF
• UDI-Device Identifier: 07290018686027
• UDI-Public: (01)07290018686027(17)340327(11)240327(10)BL1070
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K230722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 430840010
• Device Lot Number: BL1070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 08/25/2025
• Date Device Manufactured: 03/27/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown