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 United States Food and Drugs Administration (FDA) has posted a medical device safety alert concerning Alcon Research, LLC Constellation Vision System [REF: 8065751150; UDI-DI: 00380657511501; Serial Numbers: 1403028701X, 1202865201X, 0802983301X] [HKMD No.: 090145].
According to the FDA, ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage to a PCB component, that could cause component failure and loss of pressure control for the use of cutters, scissors, and forceps, which could lead to an increased risk of microbial infection, tissue damage and progressive visual impairment.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=93010
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 13 Oct 2023