Valeda light therapy devices shipped with European Union electrical configuration
Eight Valeda Light Delivery Systems are being recalled because US customers were shipped devices configured for the European Union that could not be plugged into the outlet.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA Class III recall over a regional electrical configuration that prevents the device from being connected at all, with no route to patient harm described.
Plain-English summary
The Valeda Light Delivery System, a light based device for dry age related macular degeneration, is being recalled. The action covers 8 units, identified by the serial numbers and UDI-DI codes listed in the recall notice.
The stated reason is that US customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet. The FDA classified the action as Class III, its least serious classification.
Distribution was nationwide in the United States, in Arizona, California, Florida, Illinois, North Dakota, Tennessee and Texas. The systems are supplied to eye care facilities rather than sold to consumers.
Facilities should identify affected units using the serial numbers in the recall notice and follow the instructions issued by the manufacturer.
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
- Hazard
- wrong-configuration
- electrical-plug
- cannot-be-used
- class-iii
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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