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

Catalog Number	430840010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Iritis (1940)
Date of Event	11/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that after direct selective laser trabeculoplasty procedure, the patient experienced unexpected increase in intraocular pressure.Additional information was requested and received stating that the patient had spike in post operative iop and additionally patient had bilateral iritis.The patient was started treatment with diuretic and carbonic anhydrase inhibitor twice a day, corticosteroids once a day and then twice a day for one week.There are two medical device reports associated with this patient.This report is associated with the right eye.
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
Additional information was added in h.3., h.6.And h.11.The company representative was unable to confirm nor replicate anything that would have contributed to the reported event.The system was tested and found to meet product specifications.The customer reported event cannot be confirmed.Based on the information obtained, the root cause of the reported 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.Relevant complaints were found and reviewed as part of this investigation.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 21440713
• Report Number: 3027683457-2025-00001
• Device Sequence Number: 14603600
• Product Code: HQF
• UDI-Device Identifier: 07290018686027
• UDI-Public: (01)07290018686027(17)340327(11)240327(10)BL1090
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/14/2025

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: 430840010
• Device Lot Number: BL1090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 02/22/2025
• Supplement Report FDA Received Date: 05/14/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COSOPT (PF) 2-0.5%; DROPPERETTE OU ) 0.0015%; DROPPERETTE QHS OU; GEL OU TAFLUPROST (PF; LOTEMAX SM 0.38% DROPS,; START DIAMOX TWICE A DAY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White