Bob Michaels

April 9, 2013

1 Min Read
Bausch & Lomb Implantable Lens Is Safe, FDA Panel Finds

The FDA Ophthalmic Devices Panel of the Medical Devices Advisory Committee voted that Bausch & Lomb's new implantable lens is safe for use.The company's Trulign Toric Accommodating Posterior Chamber Intraocular Lens is designed to help reduce vision distortion. In addition, the implant can help patients improve their focus on both distant and near objects without the need for glasses following cataract surgery.Toric lenses can help correct atypical vision problems like astigmatism. In addition, toric lenses can help correct blurry vision that is caused by a misshapen cornea. The company's new device is designed to correct astigmatism while still giving patients the ability to focus on objects at varying distances.Initially, reviewers at the FDA had raised concerns over some of the protocol deviations found in the study. According to the federal watchdog agency, at least 24 of these deviations may have had an impact on the accuracy of the study. Nonetheless, the device received a positive vote from the 12-member panel. A recommendation from the FDA panel does not guarantee approval with the agency.

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