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AMO approval

This article was originally published in The Gray Sheet

Executive Summary

FDA approves Advanced Medical Optics' PMA for CustomVue Monovision LASIK, the first system to allow laser treatment of one eye for distance vision and the other eye for close-up vision, the agency announces July 12. AMO acquired the device through its 2005 purchase of VISX. The company needs to conduct a 500-patient post-approval study assessing patients six months following surgery for visual disturbances...

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