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

Catalog Number	430840010
Medical Device Problem Codes	Energy Output Problem (1431); Use of Device Problem (1670)
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 physician reported about aborted treatment at 83 of 120 shots during the procedure.This occurred when treatment was completed on right eye and started on left eye.No additional information was provided.
Additional Manufacturer Narrative
Additional information was added in h.3., h.6.And h.11.The company representative was able to resolve the reported event remotely with the customer.The customer was able to successfully complete the daily start-up checks and calibrations the following day.Based on the information available, the customer reported event cannot be confirmed.It should be noted that the surgeon is a trained medical professional that in the event of an incident would mitigate those issues to proceed manually.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.(relevant not relevant).The complaints were determined to be relevant to this investigation.Based on the information obtained, 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: 21445668
• Report Number: 3027683457-2025-00005
• Device Sequence Number: 7320732
• Product Code: HQF
• UDI-Device Identifier: 07290018686027
• UDI-Public: (01)07290018686027(17)290930(11)240930(10)BL1118
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K230722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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: BL1118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 05/19/2025
• Date Device Manufactured: 09/30/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ADDERALL XR.; LATANOPROST.; WELLBUTRIN.
• Patient Age: 31 YR
• Patient Sex: Male