Summary
The FDA issued a Class II for OPMI LUMERA 300, REF 6137 by Carl Zeiss Suzhou Co., Ltd.. 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.
Details
Source
Device Recall
External ID
Z-0183-2024
Action Date
2023-11-01
Status
Ongoing
Category
device
Product Description
OPMI LUMERA 300, REF 6137
Lot/Code Info: UDI-DI/Serial Numbers: 06909262061375/6137104455, 6137104627, 6137104623, 6137104678, 6137104233, 6137104620, 6137104480, 6137104613
Quantity Affected: 8
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of MD, TX, CA, GA, LA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-18
Company
Suzhou, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 183 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Carl Zeiss Suzhou Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Carl Zeiss Suzhou Co., Ltd. have FDA actions?
This is the only FDA action we have on record for Carl Zeiss Suzhou Co., Ltd. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0183-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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