Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is
Medical device recall Z-0333-2014. Published in FDA’s Enforcement Report on Nov 27, 2013.
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 Nov 27, 2013. 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
- 4,907 units 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?
The user database delivered for download contained an erroneous value. Specifically the “aO” constant of the lens AMO Sensar AR40E is listed as “0.0” in the internal lens database of the IOLMaster. The correct value is -2.420. This could lead to the implantation of lens with a wrong diopter value.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation
4,907 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 128008 793173 793176 793179 793186 793196 797156 797185 797236 798364 798365 798366 798370 798373 798376 798413 798414 798416 798417 798426 798429 798440 798442 798444 798452 798454 798757 798759 798761 798763 798764 798765…
Every code shown here, 1,998 characters
Serial Numbers: 128008 793173 793176 793179 793186 793196 797156 797185 797236 798364 798365 798366 798370 798373 798376 798413 798414 798416 798417 798426 798429 798440 798442 798444 798452 798454 798757 798759 798761 798763 798764 798765 798768 801922 801923 801924 801927 801928 801931 801934 801937 801939 801942 801943 801944 801945 801947 801949 801952 801953 801954 801955 801958 801959 801960 801961 801962 801963 801964 801965 801972 801973 801974 801975 801978 801979 801980 801981 801983 801984 801995 801996 801997 801998 801999 802001 802002 802003 802004 802006 802007 802008 802009 802010 802011 802012 802013 802014 802015 802016 802017 804234 806022 806025 806028 806029 806031 806032 806033 806034 806036 806037 806038 806039 806041 806042 806053 806056 806058 806059 806060 806061 806062 806063 806066 806067 806068 806069 806071 806073 806074. 806075 806077 806078 806080 806082 806084 806086 806087 806088 806089 806090 806092 806094 806095 806097 806099 806100 806101 806103 806106 806107 806108 806109 806110 806111 806112 806113 806116 806122 806124 806125 806126 806127 806131 806133 806134 806135 806137 806139 806141 806143 806144 806147 806149 806150 806151 806153 806154 806155 806159 806160 806162 806164 806165 806166 806169 806170 806171 806172 806174 806175 806178 806180 806181 806183 806184 806186 806189 806191 806192 806193 806194 806195 806196 806199 806204 806205 806208 806209 806210 806211 806213 806216 806218 806219 807147 807149 807151 807152 807153 807154 807156 807157 807158 807160 807163 807165 807168 807169 807170 807172 807174 807175 807176 807178 807180 807181 807182 807183 807184 807185 807187 807191 807195 807198 807200 807201 807203 807204 807205 807209 807210 807212 807216 807218 807220 807221 807222 807223 807224 807226 807228 807229 807230 807232 807233 807234 807235 807240 807241 807242 807243 807246 807247 807248 807249 807251 807253 807254 807256 807257 807258 807260 807262 807263 807264 807265 807266 807267 807268 807271 807274…
FDA’s list runs to 32,191 characters. The first part is shown; the rest is on FDA’s record.
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 Oct 23, 2013.
- FDA classified it on Nov 15, 2013.
- FDA’s Enforcement Report published it on Nov 27, 2013.
- FDA terminated it on Apr 17, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Carl Zeiss Meditec, Inc., of Dublin, 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.”
- FDA’s list of codes runs to 32,191 characters; the first part is shown here, and the rest is on FDA’s record.
- 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.