Lenses, Soft Contact, Extended Wear
Basic Information
- Device Name
- Lenses, Soft Contact, Extended Wear
- Trade Name
- SOFTLENS66 TORIC (ALPHAFILCON A)VISIBILITY TINTED CONTACT LENSES
- PMA Number
- P960022
- Supplement Number
- S003
- Device Class
- FDA Class 3
- Product Code
- LPM
- Generic Name
- Lenses, soft contact, extended wear
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 4, 2003
- Date Received
- March 3, 2003
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A TORIC DESIGN WITH AN EXTENDED WEAR INDICATION FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR THE ABOVE REFERENCED DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BAUSCH & LOMB SOFLENS66 TORIC (ALPHAFILCONA) VISIBILITY TINTED CONTACT LENSES AND IS INDICATED FOR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS, FOR CLEANING AND DISINFECTION OR DISPOSAL OF THE LENS, AS RECOMMENDED BY THE EYE CARE PROFESSIONAL. THE LENS IS INDICATED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA, HYPEROPIA AND ASTIGMATISM) IN NOT-APHAKIC PERSONS WITH NON-DISEASED EYES, EXHIBITING ASTIGMATISM OF UP TO 5.00 DIOPTERS (D) THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THE LENS MAY BE PRESCRIBED FOR FREQUENT/PLANNED REPLACEMENT WEAR OR DISPOSABLE WEAR IN SPHERICAL POWERS RANGING FROM +6.00 D TO -9.00D WHEN PRESCRIBED FOR USE TO 7 DAYS OF EXTENDED WEAR.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPM | Lenses, Soft Contact, Extended Wear | FDA class 3 | Ophthalmic |