Device product
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
Z-2046-2025
Product summary
- Firm
- LUMITHERA INC
- Event
- Event 96892
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 8
- Official record key
device-enforcement:Z-2046-2025
Official wording
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.
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
Distribution pattern: US Nationwide distribution in the states of AZ, CA, FL, IL, ND, TN, TX.
Derived failure modes
-
Unknown
U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.