VOYAGER DSLT
Received Jul 6, 2026 · Event occurred May 28, 2026
Report 3027683457-2026-00001 · MDR key 25716050
Device
Generic name
Laser, Ophthalmic
Manufacturer
Belkin VisionModel number
NACatalog number
430840610
Lot number
ASKU
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Iritis
Narrative
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).
Description of Event or Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING DIRECT SELECTIVE LASER TRABECULOPLASTY PROCEDURE, THE PATIENT EXPERIENCED IRITIS ONE-MONTH POST PROCEDURE AND RECEIVED STEROID THERAPY THREE WEEKS AFTER THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.