Lumithera Inc. is recalling 8 units of the Valeda Light Delivery System because they were incorrectly configured for the European Union market. This error means U.S. customers received devices with electrical plugs that are not compatible with standard American wall outlets. These light-based devices are used by healthcare professionals to treat dry age-related macular degeneration.
The European plug configuration prevents the device from being plugged into a standard U.S. electrical outlet, making it impossible to power the device or provide intended treatments to patients.
Product is a light-based device for dry age-related macular degeneration.
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Sources: FDA iRES · Raw API Response
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