Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1848-2022.
During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the illumination limits by the software of the surgical microscope when "BrightCare Plus" with Luxmeter is used.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1848-2022.
Recall ongoing. Follow firm instructions.
🩺 Talk to your doctor or pharmacist
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- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1848-2022.
Leica Microsystems, Inc.
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Leica Microsystems, Inc. Recall FAQ
Leica Microsystems, Inc. is the subject of a surgical devices safety report: Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063. The notice was published on August 26, 2022 by the U.S. Food and Drug Administration (FDA). Approximately 30 units are potentially affected.