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CONSTELLATION Vision System: Recall
AUDIENCE: Eye care, Surgery, Risk Manager
ISSUE: 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.
BACKGROUND: The Alcon CONSTELLATION Vision System is an ophthalmic microsurgical system used by eye surgeons to perform various types of eye surgery. All model and catalog numbers are affected by this recall and are listed in the FDA Recall Notice. These devices were manufactured and distributed from September 1, 2008 through April 30, 2010.
RECOMMENDATION: Report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Online: www.fda.gov/MedWatch/report.htm
- Phone: 1-800-332-1088
- Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
- Fax: 1-800-FDA-0178
Read the complete MedWatch 2010 safety summary, including a link to the FDA Recall Notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm219665.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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