STAAR SURGICAL HISTORY
STAAR® developed, patented, and licensed the first foldable intraocular lens, or IOL, for cataract surgery. Made of pliable material, the foldable IOL permitted surgeons for the first time to replace a cataract patient’s natural lens with minimally invasive surgery. The foldable IOL became the standard of care for cataract surgery throughout the world. STAAR introduced its first versions of the lens, made of silicone, in 1991.
In 1996 STAAR began selling the Visian ICL® outside the U.S. Made of STAAR’s proprietary biocompatible Collamer® lens material, the ICL is implanted behind the iris and in front of the patient’s natural lens to treat refractive errors such as myopia, hyperopia, and astigmatism. Lenses of this type are generically called “phakic IOLs” or “phakic implants” because they work along with the patient’s natural lens rather than replacing it. The ICL received CE Mark in 1997, permitting sale in countries that require the European Union CE Mark, and it received FDA approval for the treatment of myopia in the U.S. in December 2005. The Visian ICL now makes up approximately 62% of our business. We sell the Visian ICL in more than 60 countries, and it has been implanted in more than 550,000 eyes worldwide.
Other milestones in STAAR’s history include the following:
- In 1991, STAAR introduced the first versions of the foldable, silicone IOL.
- In 1996, STAAR began selling the Visian ICL outside the United States.
- In 1998, STAAR introduced the Toric IOL, the first implantable lens approved for the treatment of preexisting astigmatism.
- In 2000, STAAR introduced an IOL made of the Collamer material, offering cataract patients and their surgeons the same clarity, refractive qualities and biocompatibility featured by the Visian ICL.
- In 2001, STAAR commenced commercial sales of its Visian Toric ICL® or TICL, which corrects both astigmatism and myopia, outside the U.S. In 2002, the TICL received CE Marking, allowing commercial sales in countries that require the European Union CE Mark. Today we market the TICL worldwide, except for the U.S.
- In late 2003, STAAR Japan introduced the first preloaded IOL lens injector system in international markets. The Preloaded Injector offers surgeons improved convenience and reliability. The Preloaded Injector is not yet available in the U.S.
- On December 22, 2005, the FDA approved the Visian ICL for the treatment of myopia, making it the first, and to date only, small incision phakic IOL commercially available in the United States
- Beginning in 2007, STAAR introduced its first aspheric IOLs made of silicone and Collamer.
- On December 29, 2007 , STAAR acquired the 50% remaining interests in STAAR Japan, making this former joint venture a wholly owned subsidiary of STAAR.
- On February 2, 2010, the Japanese Ministry of Health, Labor and Welfare approved the Visian ICL, making it the first phakic IOL approved for sale in Japan.
- In September, 2010, STAAR launched the expanded range Visian ICL – version V4b – in Europe and other territories that recognize the European Union CE Mark. The expanded range allows for the treatment of virtually any myopic or hyperopic refractive error.
- In April, 2011, the Visian ICL® with CentraFLOW™ – version V4c – technology received the CE Mark Approval in Europe and other territories that recognize the CE Mark. CentraFLOW technology uses a proprietary port in the center of the ICL optic. The port has a size determined to optimize the flow of fluid within the eye without affecting the quality of vision, and eliminates the need for the surgeon to perform a YAG peripheral iridotomy procedure or a surgical irid ectomy.
- In November, 2011, the Japanese Ministry of Health, Labor and Welfare approved the Toric ICL.
- In August, 2012, STAAR announced expansion to a larger facility at the Monrovia headquarters.
- In September, 2012, STAAR announced details of its direct sales model in Spain.
- In April, 2013, STAAR celebrated 350,000 Visian ICL implants.
- In June, 2013, Visian ICL V4C with CentraFlow was approved in Korea and Argentina.
- In August, 2013, Visian ICL V4C with CentraFlow was approved in India.