Constellation Vision System Recall: Problems Could Interrupt Eye Surgery

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. 

Did You Know?

AT&T Data Breach Impacts Millions of Customers

More than 73 million customers of AT&T may have had their names, addresses, phone numbers, Social Security numbers and other information released on the dark web due to a massive AT&T data breach. Lawsuits are being pursued to obtain financial compensation.

Learn More

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. 


Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Social Media Mental Health Warnings Should Be Required To Protect Teens: U.S. Surgeon General
Social Media Mental Health Warnings Should Be Required To Protect Teens: U.S. Surgeon General (Posted today)

U.S. Surgeon General says social media platforms like Facebook, Instagram and Tiktok should carry label warnings, alerting parents that youth who use the platforms face an increased risk of mental health side effects.

Camp Lejeune Contaminated Water Lawsuits To Be Selected For Track 1 Bellwether Trials
Camp Lejeune Contaminated Water Lawsuits To Be Selected For Track 1 Bellwether Trials (Posted yesterday)

Lawyers will select 25 Camp Lejeune lawsuits involving kidney cancer, bladder cancer, leukemia, non-Hodgkin's lymphoma or Parkinson's disease from a group of 100 eligible cases, which will be prepared for a series of early test trials.