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 Johnson & Johnson Surgical Vision, Inc. Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge [REF: OPOHF21L] [HKMD No.: 180389].
According to the FDA, due to a manufacturing variation of the irrigation sleeves which could result in a missing port hole, this non-conformity could lead to insufficient flow to cool the ultrasonic phaco tip, potentially leading to an unstable anterior chamber which could cause possible harms.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=94231
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 4 May 2024