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U.S. Department of Health and Human Services

Class 2 Device Recall IOLMaster 700

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  Class 2 Device Recall IOLMaster 700 see related information
Date Initiated by Firm December 07, 2020
Create Date February 18, 2021
Recall Status1 Terminated 3 on June 24, 2022
Recall Number Z-1133-2021
Recall Event ID 87055
510(K)Number K173771  
Product Classification Biomicroscope, slit-lamp, ac-powered - Product Code HJO
Product IOLMaster 700
Code Information Model: IOLMaster 700 Catalog Number device: 000000-1932-169
Recalling Firm/
Manufacturer		 Carl Zeiss Meditec AG
Carl-Zeiss-Promenade 10
Jena Germany
Manufacturer 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
FDA Determined
Cause 2		 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 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HJO and Original Applicant = Carl Zeiss Meditec AG
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