Visiogen

Visiogen, Inc. operated as an ophthalmic medical device company, establishing its headquarters in Irvine, California. Founded in 2001 by Reza Zadno, the firm focused on developing vision alternatives for patients with cataracts, including those also affected by presbyopia. The company's primary product was the Synchrony® dual-optic accommodating intraocular lens (IOL), a device designed to be implanted during cataract surgery.

The Synchrony IOL was engineered to provide a continuous range of focus, aiming to reduce or eliminate a patient's dependence on glasses after surgery. This was achieved through a unique dual-optic system connected by a spring mechanism. The design featured a high-power anterior optic and a negative-power posterior optic, which worked together to change the eye's focus, mimicking the natural accommodation of a youthful eye. The lens was customized for each patient and implanted using a pre-loaded injector through a small corneal incision.

Visiogen's business model centered on the development and eventual sale of this specialized medical device to ophthalmic surgeons and surgical centers. The company navigated the complex regulatory pathways for medical devices, securing a CE mark for the Synchrony lens in Europe, which allowed for its commercial sale starting in January 2009. In the United States, Visiogen engaged in extensive Phase III clinical trials to gain FDA approval. A significant milestone was the FDA's approval in 2007 to expand these trials. A key achievement was the successful acquisition by Abbott Laboratories in a deal announced in September 2009 and completed in October 2009 for approximately $400 million in cash. This acquisition integrated Visiogen into Abbott's growing vision care business, known as Abbott Medical Optics. Despite the acquisition and European approval, the Synchrony IOL's journey through the FDA approval process was prolonged, and the product was eventually discontinued.

Keywords: Visiogen, ophthalmic medical device, cataract surgery, presbyopia, Synchrony IOL, accommodating intraocular lens, dual-optic lens, Reza Zadno, Abbott acquisition, vision correction, ophthalmology, intraocular lens technology, medical device manufacturing, CE mark, FDA clinical trial, eye care solutions, surgical vision alternatives, refractive surgery, lens implant, eye health