FDAClass IINovember 1, 2023

Opmi Lumera 300 recall

OPMI LUMERA 300, REF 6137

Why was Opmi Lumera 300 recalled?

Surgical microscope for use in ophthalmology may be missing a screw from the suspension arm, which may cause the suspended components to fall from the suspension arm, which may injure any person under the suspended components.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI/Serial Numbers: 06909262061375/6137104455, 6137104627, 6137104623, 6137104678, 6137104233, 6137104620, 6137104480, 6137104613

Product
OPMI LUMERA 300, REF 6137
Recalling firm
Carl Zeiss Suzhou Co., Ltd.
Quantity
8
Distribution
US Nationwide distribution in the states of MD, TX, CA, GA, LA.
Recall date
November 1, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls