| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00158-1 |
| Product Name/Description |
VisuMax, VISUMAX 600 & VISUMAX 800 - Preventive laser source replacement
VISUMAX 800
Device serial number: 9511100017, 9511100001, 1249152, 9511100004, 9511100019, 9511100020, 9511100018
VisuMax
Device serial number: 1124489
ARTG 150527
(Carl Zeiss Pty Ltd - Femtosecond ophthalmic Yb: Glass laser system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
28/02/2024 |
| Responsible Entity |
|
| Reason/Issue |
Two types of laser sources for VisuMax as well as VISUMAX 600 and VISUMAX 800 are showing a systematic grating error which may occur at some point in the future. This error is detected during the startup test and the system test, when the energy transmission is measured. Since the energy measurement in the laser is performed in the optical path in front of the grating, the error appears in the product as “transmission too low”.
This constitutes a complete laser head failure, preventing the use of the product. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Carl Zeiss will be replacing the laser source in affected products and will contact affected customers to book an appointment with them to undertake this action.
customer should fill out the acknowledgment form with the customer letter to ensure they receive this replacement if required |
| Contact Information |
+61 401 480 695 - Ben Cowburn |