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
This recall is currently active, issued June 30, 2025. It was issued by Lumithera Inc.
- Company
- Lumithera Inc
- Recall Initiated
- May 7, 2025
- Posted
- June 30, 2025
- Recall Number
- Z-2046-2025
- Quantity
- 8
- Firm Location
- Poulsbo, WA
- Official Source
- View on FDA website ↗
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.
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
Root Cause
Under Investigation by firm
Action Taken
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.