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Open, Classified

OPMI LUMERA 300, REF 6137

FDA Recall Z-0183-2024 · Posted 2023-10-26

Recalling FirmCarl Zeiss Suzhou Co., Ltd.
Recall StatusOpen, Classified
Product CodeFSO
Date Initiated2023-08-18
Product Quantity8

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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