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Open, Classified

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

FDA Recall Z-2046-2025 · Posted 2025-06-30

Recalling FirmLUMITHERA INC
Recall StatusOpen, Classified
Product CodeSDE
Date Initiated2025-05-07
Product Quantity8

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.

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of AZ, CA, FL, IL, ND, TN, TX.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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