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Alcon recalls microsurgical system

Article

Alcon Laboratories is recalling a microsurgical system (Constellation Vision System) after identifying software and hardware issues associated with unexpected loss of power, unintended system error messages, unresponsive touch screens, and system setting and infusion performance problems.

Huenenberg, Switzerland-Alcon Laboratories is recalling a microsurgical system (Constellation Vision System) after identifying software and hardware issues associated with unexpected loss of power, unintended system error messages, unresponsive touch screens, and system setting and infusion performance problems. According to the FDA, these events may cause eye injuries, including blindness.

All models and catalog numbers are affected by this recall and are listed in the agency’s recall notice. These devices were manufactured and distributed between Sept. 1, 2008, and April 30, 2010.

The agency recommends that adverse events and side effects be reported to its MedWatch Safety Information and Adverse Event Reporting Program. The Web site for the program is www.fda.gov/MedWatch/report.htm; the telephone number is 800/332-1088; and the fax number is 800/FDA-0178. Also, a postage-paid FDA form 3500 may be downloaded from the MedWatch “Download Forms” page and sent to the address on the pre-addressed form.

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