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 Alcon Laboratories, Inc. DAILIES TOTAL 1 [HKMD number: 240216].
According to the TGA, a material supplied by a third-party vendor that was used in the production in an identified lot of Dailies TOTAL 1 contact lenses (for Astigmatism) at a single manufacturing site had a quality problem. As a result, the identified contact lens lot may not meet Alcon quality and/or performance standards for the entirety of their labelled shelf life.
For further information, please visit: https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00693-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 Aug 2024