FIELD SAFETY CORRECTIVE ACTION
Software Update ZEISS IOLMaster 700 with Software Versions 1.90.2.09 and 1.90.8.06
Dear valued Customer,
Thank you very much for purchasing a ZEISS IOLMaster 700. As you know, high quality and inno-vation is our main goal, but your and your patients’ safety and satisfaction is our first priority. To ensure that you are able to continue the reliable use of our system/ products with the level of high quality you expect, Carl Zeiss Meditec is planning to perform a Field Corrective Action.
Problem description:
With this letter, we would like to inform you about a software error with the
ZEISS IOLMaster 700 software versions 1.90.2.09 and 1.90.8.06. We want to give you a precise
description of the situation and provide clear guidance on how to avoid any inconveniences with your patients and in your center.
Based on post market surveillance activities, we found that the ZEISS IOLMaster 700 with soft-ware version 1.90.2.09 and 1.90.8.06, when used in conjunction with modality worklist (MWL) functionality, is not performing as expected. In rare cases this leads to a false display of patients in the patient manager screen, which can subsequently lead to the implantation of a wrong in-traocular lens (IOL).
Hazard involved:
Carl Zeiss Meditec AG has received no reports about injuries or any other adverse effects associ-ated with the described failure. In very rare cases the failure could lead to wrong measurements and subsequently wrong IOL calculation and implantation.
Affected products:
This applies only to ZEISS IOLMaster 700’s with software 1.90.2.09 and 1.90.8.06. The error only occurs, however, when the device is used in conjunction with a MWL functionality.
Actions to be taken:
In brief, a software update needs to be installed on your device, or the MWL functionality needs to be deactivated in cases where you are unable to install the software update immediately.
The software update can be downloaded starting December 7th 2020,5 pm CET via
www.zeiss.com/iolmaster-700-software-update
The software will also be made available on a USB drive at a later point.
If you are using MWL, we kindly ask you to repeat all measurements and IOL power calculations of patients that 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 implan-tation of the incorrect IOL.
Attached you can find a detailed description on how to update the software to ensure full func-tionality of your ZEISS IOLMaster 700 and how to acknowledge the successful device update.
We thank you for your careful attention and cooperation in this matter. We sincerely apologize for any inconvenience and we will do our best to address your needs and concerns.
Please do not hesitate to contact us should you have any questions.
Best regards,
Carl Zeiss Meditec AG
Attachment 1: “Acknowledgement and Receipt Form”
Attachments 2-4: “Software Installation Quick Guide” (ENG, ESP, DE) Attachment 5: “Detailed Problem Description and Action to be Taken”
Attachement 1: Acknowledgement and Receipt Form
FIELD SAFETY CORRECTIVE ACTION
Response required
Update of IOLMaster 700 with software version 1.90
Product Serial Number(s) IOLMaster 700:___________________________________________ I have read and I understand the instructions provided in the Field Safety Notice.
☐ Yes ☐ No
I confirm that I have updated my IOLMaster 700 according to the instructions provided.
☐ Yes ☐ No
I confirm that I have scrapped the Update sticks with software version 1.90.2 and / or 1.90.8 (if applicable).
☐ Yes ☐ No
I have transmitted the information to the relevant persons within my organization.
☐ Yes ☐ No
Any adverse events associated with the product?
☐ Yes ☐ No
If yes, please explain with as much detail as possible:
__________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________
Signature of Receipt:_______________________________ Date:________________________
Name / Title: Address: Phone: E-mail address:
Please send back this confirmation form:
By e-mail to: By fax to:
ZEISS IOLMaster 700 Software Update
IOLMaster 700 Software Update Instructions
1. Switch IOLMaster OFF
2. Turn IOLMaster ON
3. Go to Login screen 4. Log in as ‘Administrator’
10. Proceed with update by clicking on <Yes>
NOTE: This process will take up to 1 minute.
Please be patient.
5. Connect the USB device containing the software to the IOLMaster 700
6. Go to <Settings> (spanner icon) 7. Click on <Maintenance> 8. Scroll down to Update 9. Click on <Perform update …> Please note: This document is a preliminary version and does not replace the user manual which is delivered together with the device.
11. Select the software update from the list. 12. Click on <Run>
13. The IOLMaster will restart automatically
14. The software update will now take place, the process will take several minutes (approximately 5 - 30 minutes). Follow the instructions on the screen. In some cases a second install might be requested. The system will also guide you through it.
15. Once the software update process has completed, a dialog box will appear.
NOTE: This dialog box may appear different
depending on SW. Please take note of ‘Application’ and ‘Localization’ success. 16. Click <Close> to finish.
17. The IOLMaster will restart automatically after configuration windows updates
18. To verify successful installation of the update, proceed to <Settings>, <System Information>, <Information>
Carl Zeiss Meditec AG Goeschwitzer Strasse 51–52 07745 Jena Germany www.zeiss.com/iolmaster700 0297 EN _3 2_ 01 2_ 001 0I I In te rna tio na l v er sio n CZ -X II/ 20 20 Not all pr
oducts, services or offers ar
e appr
oved or offer
ed in every market and appr
oved labeling and instructions may vary fr
om one country
to another
. The contents of the document may differ fr
om the curr
ent status of appr
oval of the pr
oduct in your country
. Please contact our
regional r
epr
esentative for mor
e information. Subject to change in design and scope of deliver
y and as a r
esult of ongoing technical development.
IOLMaster is either a tr
ademark or a r
egister
ed tr
ademark of Carl Zeiss Meditec A
G.
© Carl Zeiss Meditec A
G, 2020. All copyrights r
ATTACHMENT:
“Detailed Problem Description and Actions to be Taken”
Software Update ZEISS IOLMaster 700 with Software Versions 1.90.2.09 and 1.90.8.06
Detailed description:
If the ZEISS IOLMaster 700 runs on software 1.90.2.09 or 1.90.8.06 and uses MWL functionality for patient and procedure data transfer to the ZEISS IOLMaster 700, the selection of the patient in the patient list of the patient management system may in rare cases not match the patient information displayed on the right side of the screen.
• There are two known manifestations of this bug:
1. The user has selected patient « A » in the patient list, but patient « B » is displayed on the right side (Figure 1).
2. The user has selected patient « A » in the patient list, patient « A » is correctly dis-played in the top right, but patient « B » is disdis-played in the bottom right (Figure 2).
Figure 1: Mismatch between patient list / upper right side and lower right side of patient manager.
DICOM Modality Worklists (MWL) make patient demographic information from a Picture Archiv-ing and Communication System (PACS, e.g. ZEISS FORUM), electronic medical records (EMR), electronic health records (EHR), or other patient management and clinic management systems available at a modality (in this case the ZEISS IOLMaster 700), eliminating dual data entry and providing data integrity. If the patient data in your office or clinic is entered in such a system and then used on the ZEISS IOLMaster 700 it is likely that an MWL functionality is used.
1. Check if you are using software version 1.90.2.09 or 1.90.8.06 AND MWL functionality
• If you are not using both,
o software 1.90.2.09 or 1.90.8.06 and o MWL functionality,
• you are not affected and can skip steps 3 and 4.
o You can view the software version of your ZEISS IOLMaster 700 by opening the device settings via the “wrench” symbol on top of every ZEISS IOLMaster 700 screen. You will immediately see the system information including the software version. (Figure 3)
o To check whether you are using a modality worklist, you need to open the device settings via the “wrench” symbol on top of every ZEISS IOLMaster 700 screen. Se-lect DICOM on the left. (Figure 4) If any of the modality worklists has the status “connected”, you need to follow the instructions provided in step 2 below and deactivate the modality worklist.
2. Download and install the software update
The software update is provided for downloading on December 7th 2020, 5 pm CET via
www.zeiss.com/iolmaster-700-software-update
• Save the update package to a USB drive or any external hard drive storage. You will need 2 GB of storage space to save all required data.
• Save or print the quick guide for software installation that can also be found on the web-site.
• Follow the steps described in the quick guide to update your ZEISS IOLMaster 700. • This software update for the ZEISS IOLMaster 700 is mandatory.
3. Deactivate MWL Functionality in case you cannot install the software update immediately
• We kindly ask you to deactivate the modality MWL on your ZEISS IOLMaster 700 in case you cannot immediately install the software update. We understand that this may cause a disruption of your current workflow, however, for the safety of your patients, this de-activation for the ZEISS IOLMaster 700 is mandatory in cases where you cannot update the software as described above.
• To deactivate the MWL functionality, you need to open the device settings via the “wrench” symbol on top of every ZEISS IOLMaster 700 screen. Select DICOM on the left then select your modality worklist and click: “Manually connect” directly under the list. (Figure 4) A window will open, in this window please “disable” the modality worklist. (Fig-ure 5)
Figure 4: Deactivation of modality worklist functionality on ZEISS IOLMaster 700.
Figure 5: Deactivation of modality worklist functionality on ZEISS IOLMaster 700.
• If you disable the MWL functionality, you will nevertheless still be able to search for pa-tients in your FORUM or EMR via the patient management list on the patient manager screen of the ZEISS IOLMaster 700. This search function is not affected by the error. The error occurs in rare cases only when the automatic creation of the MWL on the ZEISS IOLMaster 700 is activated. As an alternative you could manually enter patients on your ZEISS IOLMaster 700 directly.
4. Repeat measurements of all patients before surgery
• If you are using modality MWL, we kindly ask you to repeat all measurements and IOL power calculations of patients that 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-meas-urement assignments and implantation of the incorrect IOL.
5. Return “Acknowledgement and Receipt Form”
• We kindly ask you to send back to us the acknowledgement and receipt which you will find in Attachment 1.
