Class I Medical Device Recall: Alcon Research LTD doing business as Alcon Laboratories, Inc. - CONSTELLATION Vision System
Recall Class: Class I
Date Recall Initiated: April 30, 2010
Product: CONSTELLATION Vision System
ALL model and catalog numbers are affected by this recall.
These devices were manufactured and distributed from September 1, 2008 through April 30, 2010.
|Product Model||Catalog Number|
|Constellation Vision System with Laser||8065751145|
|Constellation Vision System Without Laser||8065751147|
Use: The Alcon CONSTELLATION Vision System is an ophthalmic microsurgical system used by eye surgeons to perform various types of eye surgery.
Alcon Research LTD doing business as Alcon Laboratories, Inc.
15800 Alton Parkway
Irvine, California 92618-3818
Reason for Recall: Alcon initiated the recall after it identified both software and hardware problems which have been associated with unexpected system loss of power (shutdowns), unintended system error messages, unresponsive touchscreens, and system setting and infusion performance problems. These events may cause eye injuries, including blindness.
Public Contact: For assistance and questions regarding the CONSTELLATION Vision System, customers may contact their Alcon Surgical Sales Representative or Alcon Technical Consumer Affairs at 1-800-561-6466, Option 8.
FDA District: Los Angeles
On July 2, 2010, Alcon sent its customers an "Urgent Medical Device Recall" letter to all its CONSTELLATION users.
The letter informed customers about the potential problem and stated that Alcon representatives will visit ALL U.S. facilities to update the software, replace the touchscreen circuit board, and to answer any questions.
This recall will not require the removal of the CONSTELLATION Vision System from any healthcare facility.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.