Z-2046-2025Class III

Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular...

Name: Z-2046-2025 Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular...
Creator: Lumithera Inc
Published: 2025-05-07
License: https://open.fda.gov/license/

Lumithera, Inc. / initiated 2025-05-07 / Open, Classified

FDA source

LUMITHERA INC began a recall of Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Product Description: Light Based Device for... on 2025-05-07. FDA classified it as Class III and gives the reason as "U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2046-2025
Classification: Class III
Status: Open, Classified
Initiated: 2025-05-07
Posted: 2025-06-30
Recalling firm: Lumithera, Inc.
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
Product code: SDE Light Based Device For Dry Age-Related Macular Degeneration
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.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 8
Distribution: US Nationwide distribution in the states of AZ, CA, FL, IL, ND, TN, TX.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2046-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2046-2025	Class III	Ongoing	Voluntary: Firm initiated	2025-07-09	2025-06-30

Product code SDE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)