DevicePMAs@therightstef:P850077_S023 / 315-319
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Approval for an alternate molded lens manufacturing process for a multifocal lens design. The device, as modified, will be marketed under the trade name sunsoft multiples(tm) and is indicated for dialy wear or extended wear from 1 to 7 days between removals for cleaning and disinfecting as recommended by the eye care professional. The lens is indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are presbyopic, with or without associated ametropia. The lens may be worn by persons who require up to +3.00 diopters (d) of add and who exhibit refractive astigmatism of no more than 1.50 d that does not interfere with visual acuity. The lens ranges in spherical power from -20.00d to +10.00 d.
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