Date Announced: 22 Apr 2019
System corrects both short-sightedness and astigmatism defects.
Bridgewater, N.J., Apr. 22, 2019 – Bausch + Lomb, a global eye health company, today announced it will initiate a series of U.S. clinical trials to evaluate the safety and efficacy of Technolas® Teneo™ excimer laser for vision correction surgery for myopia and myopic astigmatism. The company expects the clinical trials to begin by July 2019.
“The global LASIK market continues to grow, and the Technolas Teneo laser, which has a compact footprint, has been well received and widely adopted in more than 50 countries,” said Chuck Hess, vice president and general manager, U.S. Surgical, Bausch + Lomb. “Our plan to initiate a series of clinical trials, and ultimately pursue regulatory approval for this technology in the United States, is part of our commitment providing surgeons with a full suite of innovations to meet the needs of their patients.”
The system being studied will be the same as the Technolas Teneo laser (model 2) currently being sold outside the United States. Bausch + Lomb plans to file for premarket approval (PMA) of the Technolas Teneo laser from the U.S. Food & Drug Administration (FDA) at the conclusion of the clinical trials.
Source: Bausch + Lomb
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Web Site: www.bausch.com