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| |  First Implantable Contact Lenses Placed in Patients' Eyes in U.S. MONROVIA, Calif. -- March 14, 1997 -- The first implantable contact lenses (ICLs) have been implanted to start the first human clinical trials in the United States involving a new surgical procedure to correct moderate to severe myopia. The implantable lenses were manufactured by STAAR Surgical Company (NASDAQ:STAA). Two separate surgeries were performed over the past 10 days under the company's Investigational Device Exemption (IDE) granted by the U.S. Food and Drug Administration as of Feb. 20, 1997. David C. Brown, M.D., founder and director of Eye Centers of Florida in Fort Meyers, Fla., successfully implanted the first STAAR ICL in the United States when patient Teresa Morilla received one to correct approximately 8 diopters of myopia in her right eye on March 4, 1997. The procedure was successful in restoring Morilla's vision to 20/30 one day after receiving the STAAR ICL. The ICL is a technologically innovative approach patented by STAAR to correct moderate to severe myopia (near-sightedness) and hyperopia (far-sightedness) which, until now, have been corrected either by eyeglasses, or external contact lenses, which frequently provide less than satisfactory visual results. The ICL is a permanent implant and corrects vision using the same optical principles as contact lenses. Once the surgeon has chosen the proper lens power according to the patient's individual needs, the ICL is folded and inserted behind the patient's iris (colored part of the eye) and in front of the patient's natural lens using the same lens injection technology STAAR has pioneered in millions of cataract-IOL procedures. On March 6, 1997, Robert G. Martin, M.D., director and founder of the Carolina Eye Associates in Southern Pines, North Carolina, implanted the second ICL in the U.S. to correct approximately 8.5 diopters of myopia in patient Paula Allen's right eye. Prior to the procedure, Ms. Allen was considered legally blind. One day after the STAAR ICL was implanted in her right eye, the vision in that eye was better than 20/20 without the aid of eyeglasses or contact lenses. Over 400 ICLs have been implanted outside the United States. Within one day after the procedure, many of these patients saw as well without their eyeglasses or external contact lenses as they did before surgery with those same visual aids, and some patients gained even better visual acuity. ICLs are currently marketed in select European countries and South American countries, South Africa, Israel and China. Founded in 1982, STAAR Surgical Company develops, manufactures and globally distributes medical devices used in minimally invasive ophthalmic surgery.
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