PlainRecordsOPMI LUMERA 300…
- 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 suspension arm, which may injure any person under the suspended components.
- Status
- Ongoing
- Distribution
- US Nationwide distribution in the states of MD, TX, CA, GA, LA.
- Enforcement report date
- Nov. 1, 2023
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing (FDA has not recorded a termination for this recall; FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Carl Zeiss Suzhou Co., Ltd.
- Product
- OPMI LUMERA 300, REF 6137
- 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 suspension arm, which may injure any person under the suspended components.
- Distribution pattern
- US Nationwide distribution in the states of MD, TX, CA, GA, LA.
- Quantity
- 8
- Codes and lots
- UDI-DI/Serial Numbers: 06909262061375/6137104455, 6137104627, 6137104623, 6137104678, 6137104233, 6137104620, 6137104480, 6137104613
- Recall started
- Aug. 18, 2023
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Microscope, Surgical, General & Plastic Surgery
- Root cause (FDA)
- Process control
- What the company told customers
- 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.
- Recall number
- Z-0183-2024
What the record says about this device
A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.
“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.”OPMI LUMERA 300, REF 6137, FDA enforcement report, 2023-11-01. The caption is the record's own words.
A generic device, not the product. The mark follows the record's own words.
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FDA device name: Microscope, Surgical, General & Plastic Surgery
Distributed in (FDA's record): California Georgia Louisiana Maryland Texas and nationwide
This recall among the others
- FDA's enforcement report came 75 days after the firm started the recall. For half of the 835 FDA medical device recall events reported in 2023 with a start date, it took 51 days or fewer (by year).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement report, recall number Z-0183-2024. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-0183-2024, Nov. 1, 2023. "OPMI LUMERA 300." PlainRecords, https://plainrecords.com/recall/device/z-0183-2024/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections