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Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing image...

FDA Device Recall #Z-1980-2014 — Class II — June 16, 2014

Recall Summary

Recall Number Z-1980-2014
Classification Class II — Moderate risk
Date Initiated June 16, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Nidek Inc
Location Fremont, CA
Product Type Devices
Quantity 185 cameras

Product Description

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.

Reason for Recall

Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image.

Distribution Pattern

Nationwide Distribution.

Lot / Code Information

Model AFC-330: Serial numbers: 380034 380021 380035 380061 380060 380013 380011 380069 380073 380053 380055 380067 380077 380078 380017 380075 380032 380080 380081 380092 380116 380120 380237 380238 380239 380240 380241 380122 380121 380014 380211 380125 380126 380127 380124 380215 380214 380188 380221 380187 380190 380189 380212 380062 380038 380128 380223 380224 380076 380216 380213 380222 380243 380054 380042 380225 380244 380251 380252 380256 380015 380250 380074 380018 380012 380258 380068 380260 380186 380037 380253 380264 380242 380261 380262 380123 380255 380016 380052 380033 380257 380259 380004 380009 380019 380023 380027 380029 380099 380101 380103 380108 380118 380131 380134 380139 380144 380146 380147 380148 380152 380153 380155 380156 380157 380159 380160 380162 380164 380175 380177 380178 380185 380196 380198 380201 380203 380207 380208 380218 380219 380236 380008 380020 380043 380056 380058 380063 380066 380070 380071 380088 380090 380098 380102 380105 380106 380107 380111 380112 380115 380117 380119 380129 380130 380136 380140 380141 380142 380143 380145 380150 380158 380163 380176 380179 380180 380181 380182 380183 380184 380199 380200 380202 380205 380209 380210 380226 380227 380228 380230 380232 380233 380234 380235 380265 380267 380268 380269 380270 380271 380272 380273 380274 380275.

Other Recalls from Nidek Inc

Recall # Classification Product Date
Z-1494-2017 Class II Final Fit Software Version 1.11 and 1.12; PC ... Feb 1, 2017
Z-2711-2016 Class II SPECULAR MICROSCOPE CEM-530; Software version 1... Aug 8, 2016
Z-2587-2016 Class II OPTICAL BIOMETER AL-Scan: Software Version: 1.0... Jul 1, 2016
Z-1245-2016 Class II RT-5100 (Epic 5100) Refractor and RT 3100 Refra... Feb 29, 2016
Z-2477-2015 Class II OPD-Scan III Refractive Power/Corneal Analyzer ... Jun 15, 2015

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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