| TGA Action ID |
RC-2026-RN-00242-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
The CLARUS 500/700 Ophthalmic Camera
Serial Numbers: CL500-57000 or higher, CL700-75707 or higher |
| ARTG Number |
295240 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
CLARUS 700 and CLARUS 500 units were affixed with Class 4 Laser Warning Labels; however, the information for Use (IFU) shows the laser warning label as Class 3B. The devices have the correct label affixed to the units; however, the IFU was not updated to align with update Class 4 Laser Warning Label.
The laser warning in the labelling is not to mitigate any risk to users or patients, and hazard is not relevant to patients or users. The laser warning label is intended as a reminder warning to ZEISS authorized service personnel during service in addition to being informed of this in the service instructions.
This market action was taken prior to notification to the TGA. |
| Instructions for Customers/Users |
Customers are to:
- Use the device as normal
- Review the updated IFU attached to the Customer Letter or at https://www.zeiss.com/meditec/en/myzeiss/instructions-for-use.html
This action has been finalised on 8/5/2026. |
| Action Commencement Date |
7/04/2026 |
| Responsible Entity |
|
| Contact Information |
0498 477 930 - Brett Elliot, Head of Medical |