VALEDA PBM LIGHT DELIVERY SYSTEM
Received Jun 5, 2026
Report 3016232028-2026-00002 · MDR key 25410171
Device
Generic name
Light Based Device For Dry Age-related Macular Degeneration
Manufacturer
Minnetronix Inc.Model number
NACatalog number
100433473
Lot number
ASKU
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Retinal Degeneration
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 CUSTOMER REPORTED THAT THE PATIENT EXPERIENCED PROGRESSION FROM DRY AGE-RELATED MACULAR DEGENERATION TO WET AGE-RELATED MACULAR DEGENERATION AFTER RECEIVING PHOTO BIOMODULATION TREATMENT. DETAILS REGARDING THE PROCEDURE AND THE PATIENT HAVE NOT BEEN REPORTED. THIS REPORT PERTAINS TO PATIENT TWO OF THE TWO REPORTS RECEIVED FROM THE INITIAL REPORTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN RECEIVED TILL DATE.