FDA Device recall Z-0358-2016

IOL Master 500: Software versions 7.5 and 7.7

FDA Device
Class II
terminated
Published 2015-12-09

On 2015-12-09 the FDA classified a Class II recall of IOL Master 500: Software versions 7.5 and 7.7 by Carl Zeiss Meditec Ag, citing IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0358-2016
Classification	Class II
Status	terminated
Initiated	2015-10-27
Published	2015-12-09
Last updated	2026-09-13 11:53 UTC
Company	Carl Zeiss Meditec Ag
Distribution	US

Product

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.

Reason

IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.

Identifiers

code_info	Softwre versions 7.5 and 7.7; serial numbers: 1040306 1045450 1035312 1034011 1035310 1043145 1039588 1130284 1… 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 1

code_info

Softwre versions 7.5 and 7.7; serial numbers: 1040306 1045450 1035312 1034011 1035310 1043145 1039588 1130284 1…

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 1

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0358-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.