Company: Alcon Laboratories
Date of Enforcement Report 4/30//2010
Class l:
PRODUCT
CONSTELLATION Vision System
REASON
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
RECALLING FIRM/MANUFACTURER
Alcon Research LTD doing business as Alcon Laboratories, Inc., Irvine, CA
FDA District: Los Angeles
FDA Comments:
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.
