Carl Zeiss Suzhou Co., Ltd. Modern Industrial Square OPMI LUMERA 300, REF 6137 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
OPMI LUMERA 300, REF 6137
Brand
Carl Zeiss Suzhou Co., Ltd. Modern Industrial Square
Lot Codes / Batch Numbers
UDI-DI/Serial Numbers: 06909262061375/6137104455, 6137104627, 6137104623, 6137104678, 6137104233, 6137104620, 6137104480, 6137104613
Products Sold
UDI-DI/Serial Numbers: 06909262061375/6137104455, 6137104627, 6137104623, 6137104678, 6137104233, 6137104620, 6137104480, 6137104613
Carl Zeiss Suzhou Co., Ltd. Modern Industrial Square is recalling OPMI LUMERA 300, REF 6137 due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 USFCA.meditec.us@zeiss.com If you have any questions, contact firm Customer Support at 877-486-7473.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026