Opmi Lumera 300, Ref 6137 recallZ-0183-2024 · Carl Zeiss Suzhou Co., Ltd. · initiated Aug 18, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Carl Zeiss Suzhou Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Process control
What the company is doing
On 8/18/23, correction notices were mailed to customers who were asked to do the following: Before each use of the affected device, perform the following mandatory inspection: Refer to pictures in the notice showing a gap between the OPMI and the inspection arm. This gap should not be greater than 5mm. If the gap is greater than 5mm, please Immediately stop using the device! In this case the affected device can no longer be used. The firm is planning to inspect (repair if needed) the suspension arm immediately. Service staff will contact you to arrange an appointment for inspection (repair if needed) of the suspension arm. Complete and return the acknowledgement and receipt form and return to [email protected] If you have any questions, contact firm Customer Support at 877-486-7473.
Recall details
- Recall number
- Z-0183-2024
- Status
- Open, Classified
- Initiated by the company
- Aug 18, 2023
- Posted by the FDA
- Oct 26, 2023
- Recalling firm
- Carl Zeiss Suzhou Co., Ltd.
- Quantity
- 8
- Product code
- FSO
- Distribution
- US Nationwide distribution in the states of MD, TX, CA, GA, LA.
Product description
OPMI LUMERA 300, REF 6137
Code information (models, lots, serial numbers)
UDI-DI/Serial Numbers: 06909262061375/6137104455, 6137104627, 6137104623, 6137104678, 6137104233, 6137104620, 6137104480, 6137104613
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- OPMI® LUMERA® 300 6137Carl Zeiss Suzhou Co., Ltd. · Microscope, Surgical, General & Plastic Surgery1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page