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 Drug Administration (FDA) has posted a medical device safety alert concerning CooperVision Inc. BIOFINITY XR TORIC Lenses, Biofinity Toric Multifocal Lenses [HKMD No.: 240239].
According to FDA, contacted lenses manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity.
For further information, please visit: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=95299
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 03 Oct 2024
Updated on 08 Oct 2024