| Note: 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. |
| |
| Device | SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR) |
|---|
| Generic Name | Lenses, soft contact, extended wear |
|---|
| Regulation Number | 886.5925 |
|---|
| Applicant | UNILENS CORPORATION USA
10431 72nd Street North
Largo, FL 33777 |
|---|
| PMA Number | P960039 |
|---|
| Date Received | 10/30/1996 |
|---|
| Decision Date | 04/17/1997 |
|---|
|
Withdrawal Date
|
05/12/2014 |
|---|
| Product Code |
LPM |
| Docket Number | 97M-0272 |
|---|
| Notice Date | 07/08/1997 |
|---|
| Advisory Committee |
Ophthalmic |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
Approval Order Statement
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 |
| Supplements: |
S001 S002 S003 |
|
|
