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Irvine, CA-The FDA has approved Visiogen Inc.'s Investigational Device Exemption (IDE) for the Synchronym dual-optic accommodating IOL.
Irvine, CA-The FDA has approved Visiogen Inc.'s Investigational Device Exemption (IDE) for the Synchronym dual-optic accommodating IOL.
The company plans to begin U.S. clinical trials in 2005 on what it calls the first lens of its kind.
The company also has developed a pre-loaded injector for delivery of the lens, which can be inserted through a small incision. Trials outside the U.S. will begin in 2005, according to Luis Vargas, MD, the company's medical director.