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

Catalog Number	430840010
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/17/2025
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 a laser trabeculoplasty procedure the surgeon performed procedure on the wrong eye.194.5mj total energy, 119 out of 120 shots delivered.Additional information has been requested.
Additional Manufacturer Narrative
Corrected information provided in h.6.Initial mdr submitted the product problem code should be a2303 instead of a26.Additional information was added in h.3.And h.11.The company representative was unable to confirm nor replicate anything that would have contributed to the reported event.Service history was reviewed for the system.No service record relevant to the complaint reported event was found.However, the system was last serviced prior to the reported event per service record (sr) opened.The system found to meet all cosmetic and performance standards the root cause of the reported ¿surgery performed on the incorrect eye¿ event is attributed to use error.The reported ¿laser delivery¿ event cannot be confirmed.Based on the information obtained, the root cause of the reported laser delivery event is inconclusive.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.The root cause of the reported ¿surgery performed on the incorrect eye¿ event is attributed to use error.The reported ¿laser delivery¿ event cannot be confirmed.However, based on the information obtained, the root cause of the reported laser delivery 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: 21620265
• Report Number: 3027683457-2025-00006
• Device Sequence Number: 6687103
• Product Code: HQF
• UDI-Device Identifier: 07290018686027
• UDI-Public: (01)07290018686027(17)340911(11)240911(10)BL1109
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K230722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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: BL1109
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 05/30/2025
• Date Device Manufactured: 09/11/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male