Alcon has issued a recall of its Constellation Vision System for ophthalmic surgery that affects models manufactured and distributed from September 2008 through April 2010.
Alcon initiated the Class I recall of all models and catalog numbers of its Constellation ophthalmic microsurgical system after detecting software and hardware problems "associated with unexpected system loss of power (shutdowns), unintended system error messages, unresponsive touchscreens, and system setting and infusion performance problems," according to the FDA. "These events may cause eye injuries, including blindness."
The FDA says this recall does not require the removal of the Constellation Vision System from healthcare facilities. In a letter to customers earlier this month, Alcon said it was sending representatives to all facilities that have purchased the Constellation system to perform repairs and software updates.
Click here for a full list of models and catalog numbers affected by the recall. Alcon customers may contact their sales rep or Alcon Technical Consumer Affairs at (800) 561-6466 (option 8).
Irene Tsikitas
