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  5. Alcon LenSx, Inc. - 05/22/2014
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Alcon LenSx, Inc.

Alcon LenSx, Inc.

United States

Issuing Office:

United States


Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
Los Angeles District
 19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900
              Fax (949) 608-4415



May 22, 2014

Ronald M. Kurtz, M.D.
Vice President & General Manager
Alcon LenSx, Inc.
33 Journey
Aliso Viejo, California, 92656

Dear Dr. Kurtz:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [WL # 08-13, dated 12/3/2012]. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.




Alonza E. Cruse, Director
Los Angeles District

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