Skip to content
Recall Observatory FDA recall evidence

Device product

OPMI LUMERA 300, REF 6137

Z-0183-2024

August 18, 2023

Class II

Product summary

Firm
Carl Zeiss Suzhou Co., Ltd.
Event
Event 93146
Status
Ongoing
Classification
Class II
Quantity
8
Official record key
device-enforcement:Z-0183-2024

Official wording

Reason: 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.

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

Distribution pattern: US Nationwide distribution in the states of MD, TX, CA, GA, LA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.