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.

Recall Insight

This FDA Devices action (record #Z-1980-2014) was formally reported on July 9, 2014, with the manufacturer initiating the action on June 16, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Nidek Inc is listed as the recalling firm, operating out of Fremont, CA. Federal records indicate 185 cameras units are affected.

The documented reason for this recall is: Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image. Distribution data in the federal record shows the product reached: Nationwide Distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 12 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.