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Recall Observatory FDA recall evidence

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

May 07, 2025

Class III

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

    reason.no_named_rule · v1.0.0

    U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.