FDA Device recall Z-0357-2016
IOL Master 5.5: 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 5.5: 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-0357-2016 |
| 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 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation.
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 | Software versions 7.5 and 7.7: Serial numbers: 1040306 1045450 1035312 1034011 1035310 1043145 1039588…Software versions 7.5 and 7.7: Serial numbers: 1040306 1045450 1035312 1034011 1035310 1043145 1039588 1041805 1040321 1041803 1045443 1036716 1035318 1038800 1034016 1041838 1041833 1039587 1035291 1040313 1038795 1034051 1036553 1040314 1036539 1036702 1043952 1039614 1036541 1043121 1036786 1036713 1045455 1034801 1034792 1034071 1043117 1034795 1045451 1039611 1043941 1036693 1041836 1036532 1043132 1043134 1034073 1034822 1040315. |
|---|
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-0357-2016%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.