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SANTA ANA, Calif., Jan. 26 /PRNewswire-FirstCall/ -- Advanced MedicalOptics, Inc. (AMO) (NYSE: EYE), today announced that the Tecnis(R) foldableintraocular lens (IOL) has been designated as a New Technology IntraocularLens (NTIOL) by the Centers for Medicare and Medicaid Services (CMS). Thedesignation follows labeling claims approved by U.S. Food and DrugAdministration in April 2004 that the Tecnis(R) foldable IOL reducedpostoperative spherical aberrations compared to lenses with spherical opticsand improved night driving simulator performance. The NTIOL designation goesinto effect February 27, 2006 and includes both the acrylic and siliconeplatform Tecnis(R) lenses.
An NTIOL is defined as an IOL that CMS determines has been approved by theFDA for use in the labeling and advertising the IOL's claims of specificclinical advantages and superiority over existing IOLs with regard to reducedrisk of intraoperative or post-operative complication or trauma, acceleratedpostoperative recovery, reduced induced astigmatism, improved postoperativevisual acuity, more stable postoperative vision, or other comparable clinicaladvantages.
In its final notice published in the Federal Register, CMS stated, "CMSapproves AMO's claims of clinical advantages and superiority of the Tecnis(R)IOL for ocular spherical aberrations and simulated night driving. We find theAMO Tecnis(R) lenses models Z9000, Z9001, and ZA9003 meet the NTIOL definitionand are to be given the new NTIOL classification of Reduced SphericalAberration."