SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR)
FDA premarket approval P960039 · decided 1997-04-17
Approval details
- PMA number
- P960039
- Trade name
- 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
- Days to decision
- 169 days
- Decision code
- APWD
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Largo, FL
- 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
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