| Johnson & Johnson Vision has initiated this Action due to the potential for the irrigation luer to crack or break. A crack or break of the irrigation luer could lead to reduced irrigation pressure during surgery, associated with an unstable anterior chamber. This hazard could result in patient harm such as, but not limited to, capsule tear. Additionally, there could be a delay in surgery if a leakage is noticed during or prior to surgery and the pack must be switched out. As of August 29, 2022, there have been forty-one (41) product complaints, including one (1) adverse event, associated with this issue. |