Valeda Light System (Lumithera) – Configuration Error (2025)
Incorrectly configured electrical devices may prevent proper plug-in functionality.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
LUMITHERA INC
Lot Codes / Batch Numbers
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/$$+720170/16D20250311R, Serial Number 20170
Products Sold
Lot Code: UDI-DI +B749200001030/$$+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
LUMITHERA INC is recalling Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macula due to U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.
Recommended Action
Per FDA guidance
On 05/08/2025, the firm initiated sending customers an "Valeda - Return" email to inform them that the Valeda system that was distributed to them was sent with the wrong configuration. Customer were instructed to use the attached return label and return the systems back to LumiThera.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026