|Approval Order Statement |
Approval for adding software computer screens to provide precautions when refractive parameters were entered that were outside the approved indications for use. These indications for use remain: prk for the reduction or elimination of -1. 00 to -10. 00 d of spherical myopia with or without -1. 00 to -4. 00 d of astigmatism at the spectacle plane, the combination of which must result in an attempted correction between -0. 50 and -10. 00 d se at the spectacle plane where sphere or cylinder magnitude is at least 1. 00 d.