DevicePMAs@therightstef:P010018_S005 JSONTXT 11 Projects

Approval for the viewpoint ck system. The device is indicated for the temporary induction of myopia (-1.00 d to -2.00 d) to improve near vision in the non-dominant eye of presbyopic hyperopes or presbyopic emmetropes, via spherical hyperopic treatment of 1.00 to 2.25 d, in patients: 1) 40 years of age of greater; 2) with a documented stability of refraction for the prior 12 months, as demonstrated by a change of <0.50 d in spherical and cylindrical components of the manifest refraction; 3) with <=0.75 d of cycloplegic refractive cylinder; and 4) with a successful preoperative trial of monovision or history of monovision wear (i. e., dominant eye corrected for distance vision and non-dominant eye corrected for near vision).