Valeda Light Delivery System Units Shipped With Incorrect Electrical Configuration
LUMITHERA INC is recalling Valeda Light Delivery System devices configured for European electrical outlets that cannot plug into U.S. electrical outlets. Eight units were distributed across seven states.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall of a non-functional device due to incorrect electrical configuration. No illnesses or injuries have been reported, and the hazard is functional rather than safety-related.
Plain-English summary
The Valeda Light Delivery System is a light-based medical device designed to treat dry age-related macular degeneration. LUMITHERA INC discovered that eight units shipped to U.S. customers were mistakenly configured for European Union electrical standards and cannot be plugged into standard U.S. electrical outlets.
The affected devices were distributed to medical facilities in Arizona, California, Florida, Illinois, North Dakota, Tennessee, and Texas. The devices are non-functional without modification to their electrical configuration.
Customers who have received affected units should contact LUMITHERA INC for replacement or return instructions. No illnesses or injuries have been reported.
The recalled product
- 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
- Manufacturer
- LUMITHERA INC
- Category
- Medical Device — Ophthalmic
- Hazard
- power-outlet-incompatible
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 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 20170
Distribution
Distributed nationwide across the United States.
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