CONSTELLATION Vision System is a microsurgical system used to perform various eye surgeries. This system was recently recalled by the Food and Drug Administration (FDA) due to software and hardware problems associated with:
- unplanned shutdowns
- error messages
- touchscreen malfunctions
- system setting and infusion performance problems
The FDA warns that these issues may cause eye injuries, including blindness.
The devices recalled were manufactured from September 1, 2008 through April 30, 2010. The FDA’s recall notice includes specific model numbers affected by the recall.
It is recommended that any adverse events or side effects related to this product be reported to the FDA’s reporting program.