IOL Master 500: Software versions 7.5 and 7.7
Medical device recall Z-0358-2016. Published in FDA’s Enforcement Report on Dec 9, 2015.
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 Dec 9, 2015. 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
- 1882 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?
IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for 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.
1882, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Softwre versions 7.5 and 7.7; serial numbers: 1040306 1045450 1035312 1034011 1035310 1043145 1039588 1130284 1077017 1075278 1063476 1058047 1063472 1081152 1119831 1124952 1059878 1090593 1054367 1058611 1080034 1090586 1132460 1095841…
Every code shown here, 1,997 characters
Softwre versions 7.5 and 7.7; serial numbers: 1040306 1045450 1035312 1034011 1035310 1043145 1039588 1130284 1077017 1075278 1063476 1058047 1063472 1081152 1119831 1124952 1059878 1090593 1054367 1058611 1080034 1090586 1132460 1095841 1095836 1066448 1097694 1132525 1105634 1130344 1126762 1055245 1059877 1086809 1053566 1101702 1092639 1057182 1095824 1083506 1119231 1126790 1065670 1063475 1081192 1075271 1117159 1098299 1139278 1083484 1132509 1145130 1092692 1115088 1124953 1126802 1052948 1125668 1082378 1120161 1065538 1046056 1126781 1114267 1062550 1047513 1082373 1117483 1061193 1119272 1054344 1047283 1126780 1139261 1082370 1124902 1115519 1056018 1094054 1086662 1057165 1070204 1136306 1120661 1057131 1071745 1064967 1055248 1065582 1057455 1074568 1061185 1115068 1072995 1071617 1117511 1115494 1086658 1094075 1120657 1139275 1090589 1109370 863459 1083470 1108209 1109383 1071717 1125777 1107530 1088296 1075800 1046381 1132604 1083487 1101714 1108203 1094067 1073000 1060609 1097080 1102092 1112204 1064334 1080889 1105629 1125669 1081150 1081189 1058045 1101723 1063500 1074562 1102095 1071619 1115514 1101704 1074935 1060614 1047275 1081147 1070773 1136304 1078173 1089285 1086818 1049604 1124851 1092632 1071741 1070772 1065674 1075276 1098295 1126721 1110334 1059885 1126786 1065667 1086819 1130280 1097076 1111751 1065584 1108206 1105002 1105898 1108205 1126760 1126734 1097079 1126732 1124936 1124933 1115487 1125723 1075536 1117497 1117157 1062564 1072994 1097092 1047268 1058650 1092635 1070154 1076553 1125772 1049603 1126796 1080451 1094049 1052917 1054369 1109030 1057181 1066452 1124921 1115524 1061190 1111474 1073009 1067639 1143719 1125687 1094060 1072832 1116720 1080881 1073005 1103021 1061214 1075273 1092638 1053213 1111455 1083468 1139298 1050566 1065668 1130300 1136291 1067068 1057177 1058629 1094072 1102094 1057115 1080666 1124863 1130356 1052942 1053561 1061219 1056451 1102098 1075564 1080880 1119248 1095378 1065638 1082396 1120163 1116691…
FDA’s list runs to 15,932 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 27, 2015.
- FDA classified it on Dec 1, 2015.
- FDA’s Enforcement Report published it on Dec 9, 2015.
- FDA terminated it on Jun 6, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Carl Zeiss Meditec AG, of Jena, Germany.
- 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 15,932 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
-
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.