MAUDE Adverse Event Report: BELKIN VISION VOYAGER DSLT; LASER, OPHTHALMIC

Catalog Number	430840610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	10/10/2025
Type of Reportable Event	Serious Injury
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 that patient experience trans illumination defect during surgery.The patient was treated with corticosteroids and carbonic anhydrase inhibitors.
Additional Manufacturer Narrative
Additional information was added in h.3.,h.6.And h.11.Service history was reviewed for the system.There was no service record (relevant to the reported event), found.There was no previous service prior to the reported event (other than installation), per the service record (sr).All surgical systems are verified to meet specifications after installation and customer initiated servicing, in accordance with the applicable procedures.Based on the assessment, the product met release criteria.Based on the information obtained, the root cause of the reported event remains inconclusive.A review for ¿complaints reported against this serial number¿ was performed.A relevant complaint was found and reviewed as part of this investigation.This complaint was determined to be relevant, due to the same time frame.The reported event revealed an issue with the scanner shot positioning, resulting in the console being replaced.The reported ¿iris transillumination¿ is categorized as an adverse event tied to ¿iris defect.¿ the issue is seen when viewed with a slit lamp (post-operatively) and shows where pigment has been lost.According to clinical information, ¿these defects are generally painless, and patients are typically asymptomatic.¿ there was no service record for the system (relevant to the reported event), found.Therefore, based on the information obtained, the root cause of the reported event remains inconclusive.The manufacturer internal reference number is: (b)(4).

• Brand Name: VOYAGER DSLT
• 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 ; +972 0547999997
• MDR Report Key: 23801647
• Report Number: 3027683457-2025-00031
• Device Sequence Number: 20738618
• Product Code: HQF
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2026

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: 430840610
• Device Lot Number: BL1351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 06/25/2026
• Date Device Manufactured: 06/19/2025
• 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: ESOMEPRAZOLE MAGNESIUM 20 MG ORAL; ESOMEPRAZOLE MAGNESIUM 20 MG ORAL.; FAMOTIDINE 20 MG ORAL; FAMOTIDINE 20 MG ORAL.; FLUTICASONE PROPIONATE 50 MCG/ACTUATION; FLUTICASONE PROPIONATE 50 MCG/ACTUATION.; LATANOPROST 0.005 % OPHTHALMIC; LATANOPROST 0.005 % OPHTHALMIC.; SUCRALFATE 1 GRAM ORAL; SUCRALFATE 1 GRAM ORAL.; TRAMADOL 50 MG; TRAMADOL 50 MG.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Female