PMA_MER  

DevicePMAs@therightstef:P850078_S000 JSONTXT 11 Projects

Approval for the spherical and toric configurations of the kontur softmethafilcon a hy4rophilic contact lens the spherical lens is indicated fordaily wear for the correction of visual acuity in aphakic and not aphakicpersons with nondiseased eyes that are myopic or hyperop1c the lens may be worn by persons who exhibit refractive astigmatism of 1 50 diopters d or less that does not interfere with visual acuity the lens ranges 1n powers from 20 00 d to 20 00 d the toric lens is indicated for daily wear for the correction of visual acuity 1n not aphakic persons w1th nond1seased eyes that are myopic hyperopic or have refractive astigmatism not exceeding 5 00 d that does not 1nterfere with visual acuity the lens canges in powers from 20 00 d to 10 00 d both configurations of the lens are to be disinfected using a chemical lens care system.

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