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.
Medical device manufacturer, Johnson & Johnson Vision, has posted a medical device safety alert concerning its TECNIS Symfony IOLs (ZXR00) and TECNIS Eyhance IOLs (ICB00) [HKMD No.: 180436 and 190123].
The manufacturer is initiating a recall due to identification of a limited quantity of non-toric TECNIS IOLs that were manufactured with unintended toric fiducial marks. According to the manufacturer, the non-toric lenses containing the fiducial marks have no impact to optical performance or clinical impact to the patient's outcomes.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 04 Jul 2023