Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Ma...
FDA Recall #Z-2046-2025 — Class III — May 7, 2025
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
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.
Recalling Firm
LUMITHERA INC — Poulsbo, WA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
8
Distribution
US Nationwide distribution in the states of AZ, CA, FL, IL, ND, TN, TX.
Code Information
Lot Code: UDI-DI +B749200001030/$$+720172/16D20250311T; Serial Number 20172 UDI-DI +B749200001030/$$+720166/16D20250311W; Serial Number 20166 UDI-DI +B749200001030/$$+720167/16D20250311X; Serial Number 20167 UDI-DI +B749200001030/$$+720168/16D20250311Y; Serial Number 20168 UDI-DI +B749200001030/$$+720169/16D20250311Z; Serial Number 20169 UDI-DI +B749200001030/$$+720175/16D20250311W; Serial Number 20175 UDI-DI +B749200001030/$$+720177/16D20250311Y; Serial Number 20177 UDI-DI +B749200001030/$$+720178/16D20250311Z; Serial Number 20178 Update 14 May 2025: UDI-DI +B749200001030/$$+720170/16D20250311R; Serial Number 20170
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated