Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for Recalled by Nidek Inc Due to Image taken by AFC-330 has a white spot...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Nidek Inc directly.
Affected Products
Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye. Distributed by Nidek, Inc, and Marco Opthalmic Inc. Manufactured by Nidek Co. Ltd, Japan.
Quantity: 185 cameras
Why Was This Recalled?
Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Nidek Inc
Nidek Inc has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report