FDA Medical Device Recalls (openFDA)
Carl Zeiss Meditec AG: IOLMaster 700
- Recall number
- Z-1133-2021
- Recalling firm
- Carl Zeiss Meditec AG
- Product
- IOLMaster 700
- Status
- Terminated
- Initiated
- 2020-12-07
- Posted
- not on file
- Terminated
- 2022-06-24
- Reason
- 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
- 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 USFCA.meditec.us@zeiss.com or by fax 925-448-3880 For any questions, contact Customer Support at 877-486-7473.
- Quantity
- 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.
- Lot, serial or model codes
- Model: IOLMaster 700 Catalog Number device: 000000-1932-169
- 510(k) numbers
- ["K173771"]
- PMA numbers
- not on file
- Product code
- HJO
- Firm FEI
- 3001362763
- Firm city
- Jena
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28