IOLMaster 700

Date

Feb. 24, 2021

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Carl Zeiss Meditec AG

Product

IOLMaster 700

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

Distribution pattern

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.

Quantity

613 devices

Codes and lots

Model: IOLMaster 700 Catalog Number device: 000000-1932-169

Recall started

Dec. 7, 2020

Device type

Biomicroscope, Slit-Lamp, Ac-Powered

Root cause (FDA)

Software design

What the company told customers

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.

Recall number

Z-1133-2021

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1133-2021. The agency record governs; check it and the company before acting.