Z-2046-2025 Class III Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 9, 2025
- Initiation Date
- May 7, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8
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
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 Pattern
US Nationwide distribution in the states of AZ, CA, FL, IL, ND, TN, TX.
Code Information
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