Z-1133-2021Class II

IOLMaster 700

Name: Z-1133-2021 IOLMaster 700
Creator: Carl Zeiss Meditec AG
Published: 2020-12-07
License: https://open.fda.gov/license/

Carl Zeiss Meditec Inc / initiated 2020-12-07 / Terminated / root cause: software

FDA source

Carl Zeiss Meditec AG began a recall of IOLMaster 700 on 2020-12-07. FDA classified it as Class II and gives the reason as "When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient list may not match the patient information displayed on the...". 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-1133-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-07
Posted: 2021-02-18
Terminated: 2022-06-24
Recalling firm: Carl Zeiss Meditec Inc
Product: IOLMaster 700
Product code: HJO Biomicroscope, Slit-Lamp, Ac-Powered
Reason for recall: When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient list may not match the patient information displayed on the right side of the screen
Root cause tag: software
FDA root cause: Software design
Action: On 12/11/2020, the firm sent a "FIELD SAFETY CORRECTION ACTION URGENT MEDICAL DEVICE RECALL" Notification Letter via UPS informing them about a software error with software versions 1.90.2.09 and 1.90.8.06 that when used in conjunction with modality worklist functionality, is not performing as expected. These issues may lead to false display of patients in the patient manager screen, which can subsequently lead to the implantation of a wrong intraocular lens (IOL). The Recalling Firm is informing it customers that a software update needs to be installed on their device(s), or the modality worklist functionality (MWL) needs to be deactivated in case where they are unable to install the software update immediately. Software update will be available starting December 7th 2020 11 am ET via www.zeiss.com/iolmaster-700-software-update-us. The software will also be made available on a USB drive at a later point. If customers are using MWL, the Recalling Firm is asking them to repeat all measurements and IOL power calculations of patients that have underwent measurements with software 1.90.2.09 or 1.90.8.06 and have not yet undergone surgery to mitigate the risk of wrong patient measurement assignments and implantation of the incorrect IOL. Customers are asked to complete and return the Acknowledgement and Receipt Form via e-mail to [email protected] or by fax 925-448-3880 For any questions, contact Customer Support at 877-486-7473.
Quantity in commerce: 613 devices
Distribution: U.S.: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, TX, UT, VA, VT, WA, WI, and WV. O.U.S.: Austria, Australia, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, France, United Kingdom, Guatemala, Hong Kong, Indonesia, Ireland, India, Italy, Japan, Kuwait, Malaysia, Netherlands, New Zealand, Philippines, Poland, Portugal, Russia, Sweden, Singapore, Slovakia, Thailand, Taiwan, and South Africa.
Product codes and lots: Model: IOLMaster 700 Catalog Number device: 000000-1932-169

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1133-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1133-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-24	2021-02-18

Product code HJO

K173771Class IIIOLMaster 700Carl Zeiss Meditec, AG / cleared 2018-08-24

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)