Z-0357-2016Class II

IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform...

Name: Z-0357-2016 IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform...
Creator: Carl Zeiss Meditec AG
Published: 2015-10-27
License: https://open.fda.gov/license/

Carl Zeiss Meditec Inc / initiated 2015-10-27 / Terminated / root cause: software

FDA source

Carl Zeiss Meditec AG began a recall of 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... on 2015-10-27. FDA classified it as Class II and gives the reason as "IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0357-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-27
Posted: 2015-12-01
Terminated: 2016-06-06
Recalling firm: Carl Zeiss Meditec Inc
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.
Product code: HJO Biomicroscope, Slit-Lamp, Ac-Powered
Reason for recall: IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
Root cause tag: software
FDA root cause: Software design
Action: Urgent Medical Device Correction letters will be mailed on Friday, November 13, 2015 as the IOL SW update material is now available. Letter informs customers of the issue and provide instructions for identifying the software version and for installing the software update with illustrations. All customers are requested to complete and return the confirmation form to Stericycle as soon as the upgrade is complete or it has been determined that your unit is not running the affected version of the software.
Quantity in commerce: 49
Distribution: Nationwide Distribution.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0357-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0357-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-09	2015-12-01
Z-0358-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-09	2015-12-01

Product code HJO

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)