Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Pro
Summary
The FDA issued a Class III for Brand Name: Valeda Light Delivery System Product Name: Light Based Device for D by LUMITHERA INC. Reason: U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet..
Details
Source
Device Recall
External ID
Z-2046-2025
Action Date
2025-07-09
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: 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 20178 Update 14 May 2025: UDI-DI +B749200001030/$$+720170/16D20250311R; Serial Number 20170
Quantity Affected: 8
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.
Distribution
US Nationwide distribution in the states of AZ, CA, FL, IL, ND, TN, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-07
Company
Poulsbo, WA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 153 device recalls issued in the same week, part of 403 device-related FDA actions this month.
LUMITHERA INC has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (LUMITHERA INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does LUMITHERA INC have FDA actions?
LUMITHERA INC has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2046-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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