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B&L receives FDA clearance for Zywave aberrometer
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ROCHESTER, N.Y. — Bausch & Lomb (NYSE: BOL) has received U.S. Food and Drug Administration approval to market its Zywave aberrometer, a diagnostic device that enables examination of the eye's entire optical system.
The Zywave aberrometer uses wavefront technology, in which a beam of light is reflected off the retina to determine the unique features of each eye and identify abnormalities throughout the entire optical system. In eyes where there is an abnormality, the measurement of the variations between the actual direction of the outgoing beams of the light and their optimal positions determines the overall aberration of the eye.
After receiving an approved investigational device exemption (IDE) from the FDA earlier this year, Bausch & Lomb is currently conducting an 80-eye clinical study of its Zyoptix system in the United States.
The Zyoptix system integrates information gathered by the advanced diagnostics of the Orbscan II (a multi-dimensional system for mapping the anterior and posterior surfaces of the cornea and measuring corneal thickness) and the Zywave, enabling surgeons to design individually tailored treatments for their patients. Earlier this week, B&L announced it received Canadian marketing approval for Zyoptix.