This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the soft-55 ew aphakic (vifilcon a) soft (hydrophilic) contact lenses for extended wear. This device is indicated for extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. The lenses are indicated for the correction of visual acuity in aphakic persons (after cataract surgery) that are myopic or hyperopic. Soft-55 ew aphakic lenses may be worn by persons who may exhibit astigmatism of 2. 00 diopters or less that does not interfere with visual acuity
| Device | SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR) |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | UNILENS CORPORATION USA |
| Date Received | 1996-10-30 |
| Decision Date | 1997-04-17 |
| Notice Date | 1997-07-08 |
| PMA | P960039 |
| Supplement | S |
| Product Code | LPM |
| Docket Number | 97M-0272 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | UNILENS CORPORATION USA 10431 72nd Street North largo, FL 33777 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P960039 | Original Filing | |
| S003 | 2007-12-31 | 135 Review Track For 30-day Notice |
| S002 | 2001-01-29 | Normal 180 Day Track |
| S001 | 1998-06-25 | 30-day Notice |