Approval for the horizon 55 ew and horizon 55 ew westint (methafilcon a) soft hydrophilic contact lenses for extended wear (clear and visibility tint). These devices are indicated for extended wear from 1 to 7 days between removel for cleaning, rinsing and disinfecting as recommended by the eye care practitioner. The lenses are indicated for the correction of visual acuity in not-aphakic persons with non diseased eyes that are myopic or hyperopic. The lenses may be worn by persons who exhibit astigmatism of 1. 50 diopters or less that does not interfere with visual acuity.
| Device | W-55 (METHAFILCON A) AND HORIZON 55 SOFT EXTENDED WEAR CONTACT LENSES |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | WESTCON CONTACT LENS CO., INC. |
| Date Received | 1999-11-16 |
| Decision Date | 2000-08-22 |
| Notice Date | 2000-08-31 |
| PMA | P990072 |
| Supplement | S |
| Product Code | LPM |
| Docket Number | 00M-1475 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | WESTCON CONTACT LENS CO., INC. 611 Eisenhauer St. grand Junction, CO 81505 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990072 | Original Filing |