Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Carl Zeiss Meditec AG VisuMax, [Serial number: 1124489] VISUMAX 600 & VISUMAX 800 [Serial number: 9511100017, 9511100001, 1249152, 9511100004, 9511100019, 9511100020, 9511100018] [[HKMD number: 100181].
According to the TGA, the manufacturer has identified 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.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00158-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 1 Mar 2024