Vision system recall is Class I
This article was originally published in The Silver Sheet
Executive Summary
Alcon has recalled all models of its Constellation vision system, a microsurgical system used in various types of eye surgery. Alcon said it identified software and hardware problems that can cause unexpected system shutdowns, unintended error messages, unresponsive touch screens and other performance problems, which could cause eye injuries, including blindness. FDA classified the recall as Class I