|Trade Name||FREQUENCY MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR (CLEAR AND TINTED)|
|Classification Name||lenses, soft contact, extended wear|
|Generic Name||soft hydrophilic contact lenses|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - indications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the frequency multifocal (methafilcona) soft (hydrophilic) contact lenses for extended wear (clear and tinted). The lenses are indicated for extended wear from 1 to 7 days between removals for cleaning and disinfecting as recommended by the eye care practitioner. They are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic. The lenses may be worn by persons who exhibit astigmatism of 2. 00 diopters or less that does not interfere with visual acuity.