FDA recall Z-2046-2025

LUMITHERA INC · Class III · device

Product

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

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-05-07
Report date
2025-07-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Poulsbo, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2046-2025