Federal regulators are warning that the Constellation Vision System, a medical device used to perform eye surgery, has hardware and software problems that could result in an injury for patients.
The FDA announced this week that a Constellation Vision System recall issued earlier this month constitutes a Class 1 medical device recall, indicating that the defect has a substantial likelihood to result in serious injury or death. The recall was first issued by Alcon Research Ltd., the manufacturer, after it identified both software and hardware problems with the system.
Problems with the device could cause unexpected power loss and shut downs of the machines, unintended system errors, touchscreens that become unresponsive and performance problems. These could lead to a patient suffering a serious eye injury or blindness, the FDA concluded.
The recall affects all Alcon Constellation Vision Systems, which are ophthalmic microsurgical systems used by eye surgeons to conduct various types of eye surgery, according to the FDA’s recall announcement. All models and catalog numbers are affected by the recall, including:
- Constellation Vision System with Laser; Catalog No. 8065751145
- Constellation Vision System without Laser; Catalog No. 8065751147
- Constellation Tabletop; Catalog No. 8065751150
- Constellation XT; Catalog No. 8065751548
- Constellation LT; Catalog No. 8065751549
- Constellation LXT; Catalog No. 8065751550
- Constellation LX; Catalog No. 8065751551
- Constellation B; Catalog No. 8065751552
- Constellation X; Catalog No. 8065751553
- Constellation L; Catalog No. 8065751554
- Constellation T; Catalog No. 8065751558
The devices were sold between September 1, 2008 and April 30, 2010.
The FDA says that Alcon sent a letter to customers on July 2, informing them of the problems. Although the FDA and Alcon classify it as a recall, the devices will not be removed from healthcare facilities. Instead, Alcon representatives will visit all of the customers and update the software and replace the touchscreen circuit board.