LUMITHERA INC recalls Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Prod…

Recall date

May 7, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2046-2025

FDA classification

Class III

Brand / firm

LUMITHERA INC

Sold / distributed

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

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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