LUMITHERA INC: 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 De

Hazard

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

Details from the source

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. Quantity: 8 Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.