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.
FDA Recall Z-1980-2014 · Posted 2014-07-02
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Recalling FirmNidek Inc
Recall StatusTerminated
Product CodeHKI
Date Initiated2014-06-16
Date Terminated2015-03-03
Product Quantity185 cameras
Reason for Recall
Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image.
Firm Action
Field Correction notifications were sent to all affected users on June 16, 2014 by trackable method.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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