Non-Mydriatic Auto Fundus Camera
Medical device recall Z-1980-2014. Published in FDA’s Enforcement Report on Jul 9, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 9, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 185 cameras how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
185 cameras, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,326 characters
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.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide Distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 16, 2014.
- FDA classified it on Jul 2, 2014.
- FDA’s Enforcement Report published it on Jul 9, 2014.
- FDA terminated it on Mar 3, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Nidek Inc, of Fremont, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.