Z-0183-2024Class II

Opmi Lumera 300, Ref 6137

Name: Z-0183-2024 Opmi Lumera 300, Ref 6137
Creator: Carl Zeiss Suzhou Co., Ltd.
Published: 2023-08-18
License: https://open.fda.gov/license/

Carl Zeiss Suzhou Co., Ltd. / initiated 2023-08-18 / Open, Classified / root cause: manufacturing process

FDA source

Carl Zeiss Suzhou Co., Ltd. began a recall of OPMI LUMERA 300, REF 6137 on 2023-08-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0183-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-18
Posted: 2023-10-26
Recalling firm: Carl Zeiss Suzhou Co., Ltd.
Product: Opmi Lumera 300, Ref 6137
Product code: FSO Microscope, Surgical, General & Plastic Surgery
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 8
Distribution: US Nationwide distribution in the states of MD, TX, CA, GA, LA.
Product codes and lots: UDI-DI/Serial Numbers: 06909262061375/6137104455, 6137104627, 6137104623, 6137104678, 6137104233, 6137104620, 6137104480, 6137104613

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0183-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0183-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-26

Product code FSO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)