Reported Jul 9, 2025 · Ongoing
Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration…
Lumithera Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LUMITHERA INC · 19578 10th Ave Ne Ste 200 · Poulsbo, WA · 98370-7332
Is this the product you have?
- Brand NameValeda
- Light Delivery System Product NameLight Based Device for Dry Age Related Macular
- Degeneration Product DescriptionLight Based Device for Dry Age
- Related Macular Degeneration ComponentNo
- Lot codes and dates
10 of 10 products
Products covered by this recall # Product as published 1 Lot Code: UDI-DI +B749200001030/$$+720172/16D20250311T 2 Serial Number 20172 UDI-DI +B749200001030/$$+720166/16D20250311W 3 Serial Number 20166 UDI-DI +B749200001030/$$+720167/16D20250311X 4 Serial Number 20167 UDI-DI +B749200001030/$$+720168/16D20250311Y 5 Serial Number 20168 UDI-DI +B749200001030/$$+720169/16D20250311Z 6 Serial Number 20169 UDI-DI +B749200001030/$$+720175/16D20250311W 7 Serial Number 20175 UDI-DI +B749200001030/$$+720177/16D20250311Y 8 Serial Number 20177 UDI-DI +B749200001030/$$+720178/16D20250311Z 9 Serial Number 20178 Update 14 May 2025: UDI-DI +B749200001030/$$+720170/16D20250311R 10 Serial Number 20170 - Amount recalled
- 8
Where it was sold
Why it was recalled
U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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