| TGA Action ID |
RC-2025-RN-00920-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
EYESUITE MYOPIA for Lenstar LS 900 and Eyestar 900
Affected Versions: i9.13.0.1 and below
DT Product Code: HS-7221017
Part Number: 1023815, 7221017 |
| ARTG Number |
375298 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Under certain circumstances, when switching to a patient’s file while a previous patient is still selected, the chart displayed in Eye Suite Myopia may not update correctly and may continue to show the previous patient’s data.
This problem may result in the presentation of incorrect data to a patient, potentially leading to misinterpretation of treatment progress.
To date, there has been one case of this problem occurring reported in Australia. |
| Instructions for Customers/Users |
- A software update that resolves this problem is available.
- In the interim customers who have devices with EyeSuite Myopia i9.13.0.0 or below are to follow these precautions:
·Close the current patient file before opening a new one.
·Confirm the patient’s identity in the header before interpreting graphs.
·Check charts for plausibility and cross-reference with tabular values or alternative displays.
·If a mismatch is suspected, restart EyeSuite.
- To identify the version of the installed software, open EyeSuite. In the menu bar click on the ?-icon. Select About EyeSuite.
- Customers who have indicated in the Customer Response Form to own devices that require the software upgrade, will be contacted by Device Technologies.
This action has been closed out on 13/05/2026. |
| Action Commencement Date |
24/10/2025 |
| Responsible Entity |
|
| Contact Information |
1300 338 423 - Device Technologies |