Alcon Research LTD, which is doing business as (DBA) Alcon Laboratories, Inc. (15800 Alton Parkway, Irvine, California, 92618-3818), has issued a Class I recall of its <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">Constellation Vision System, according to the U.S. Food and Drug Administration (FDA). 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.
The recall involves all model and catalog numbers and includes devices manufactured and distributed from September 1, 2008 through April 30, 2010. The complete listing appears in the FDA Recall Notice, which can be accessed here.
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 touch screens, and system setting and infusion performance problems. These events may cause eye injuries, including blindness.
The Alcon Constellation Vision System is an ophthalmic microsurgical system used by eye surgeons to perform various types of eye surgery.
For assistance and questions regarding the Constellation Vision System, customers may contact their Alcon Surgical Sales Representative or Alcon Technical Consumer Affairs, toll-free, at 1-800-561-6466, Option 8. The FDA District involved is Los Angeles.
On July 2, 2010, Alcon an “Urgent Medical Device Recall” letter to all its Constellation users informing customers about the potential problem. The letter stated that Alcon representatives will visit ALL U.S. facilities to update the software, replace the touch screen circuit board, and answer any questions.
This recall will not require removal of the Constellation Vision System from any healthcare facility.
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 at www.fda.gov/MedWatch/report.htm; by telephone, toll-free at 1-800-332-1088; by regular mail by returning the postage-paid FDA form 3500, which may be downloaded from the MedWatch “Download Forms” page, to address on the pre-addressed form; or by fax to: 1-800-FDA-0178.