Class III

Medical Device Recall: Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Product Description: Light Based Device for Dry Age Related Macular Degeneration C

LUMITHERA INC · May 7, 2025

Reason for Recall

U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.

Product Description

Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Product Description: Light Based Device for Dry Age Related Macular Degeneration Component: No

Distribution

US Nationwide distribution in the states of AZ, CA, FL, IL, ND, TN, TX.

States Affected

NATIONWIDE

Quantity Affected

8

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2046-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.