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 Oculus Optikgerate GmbH Pentacam AXL (Type 70100) and Pentacam AXL Wave (Type 70020) [Serial numbers: 70020 0731 2290, 70020 9731 2290, 70020 7041 2221 and 70020 9631 2290] [HKMD No.: 200137].
According to the TGA, one of the suppliers did not meet the specifications for an optical component inside the devices. An insufficient anti-reflective coating was found, which under certain circumstances can lead to an additional axial length signal. If the correct axial length signal is weaker (e.g. due to an off-centre measurement or a cataract), an incorrect axial length value can be displayed. The manufacturer identified the problem within the production process.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00726-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 Aug 2023