|Trade Name||SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)EXTENDED WEAR CONTACT LENS|
|Classification Name||lenses, soft contact, daily wear|
|Generic Name||methafilcon a soft (hydrophilic) contact lens|
|Supplement Type||normal 180 day track|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
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.