DevicePMAs@therightstef:P990027_S006 JSONTXT 11 Projects

Approval for the bausch & lomb technolas 217z zyoptix system for personalized vision correction. The device uses an optical zone size between 6.0 mm and 7.0 mm with a constant blend zone of .875 mm, and is indicated for wavefront-guided laser assisted in-situ keratomileusis (lasik): 1) for the reduction or elimination of myopia with sphere up to -7.00 d and cylinder up to -3.00 d and mrse <=7.50 d at the spectacle plane; 2) in patients with documented evidence of a change in manifest refraction of less than or equal to +=0.50 diopters (in both cylinder and sphere components) for at least one year prior to the date of the pre-operative examination; and 3) in patients 21 years of age or older.