SofLens Toric (Alphafilcon A) Soft Contact Lenses
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- SOFLENS66(TM) FDA PMA
- Generic Name
- Lenses, soft contact, extended wear FDA PMA
Identifiers
- PMA Number
- P960022 FDA PMA
- FDA Product Code
- LPM FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 886.5925 FDA PMA
- Regulation Number
- 886.5925 FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The SofLens Toric (Alphafilcon A) Soft Contact Lenses are classified as Lenses, Soft Contact, Extended Wear, designed to correct refractive errors while accommodating astigmatism. These toric lenses provide continuous wear for up to 30 days, offering extended comfort and vision correction for patients with irregular corneal curvature.
These lenses are supplied as single-use disposable units and are intended for professional fitting by ophthalmic practitioners. They are not sterile upon packaging and must be handled under aseptic conditions before use. The device holds an FDA PMA authorization (P960022) and is regulated under classification III (886.5925) for ophthalmic applications. Multiple product codes (e.g., LPM) and registration numbers are associated with this device.
Frequently asked questions
Are these contact lenses designed for continuous wear, and if so, how long can they be worn without removal?
Yes, the SofLens Toric (Alphafilcon A) Soft Contact Lenses are classified as extended-wear lenses, meaning they are designed for continuous wear. These lenses are authorized for up to 30 days of continuous use, providing extended comfort and vision correction for patients with astigmatism.
How are these lenses supplied, and do they require sterilization before use?
These lenses are supplied as single-use disposable units, meaning each lens is intended for one patient only. They are not sterile upon packaging and must be handled under aseptic conditions by a professional before insertion into the patient’s eye.
What regulatory pathway was followed for approval of these lenses, and what classification do they fall under?
The SofLens Toric lenses hold an FDA Premarket Approval (PMA) authorization under PMA number P960022. They are classified as Class III medical devices under regulation number 886.5925, which applies to ophthalmic devices requiring extended wear.
Are these lenses intended for professional fitting only, and if so, why?
Yes, these lenses are explicitly intended for professional fitting by ophthalmic practitioners. This is because they are designed for extended wear (up to 30 days) and require precise measurement and fitting to ensure proper corneal curvature alignment and patient safety.
What is the primary material used in these lenses, and how does it relate to their extended-wear capability?
The lenses are made from Alphafilcon A, a silicone hydrogel material. This material allows for higher oxygen permeability compared to traditional hydrogel lenses, which supports extended wear by reducing corneal hypoxia and maintaining eye health during prolonged use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Bausch + Lomb Official Home Page, Anmelden | Bausch Germany MC Site, Startseite | Bausch + Lomb, Produkte | Bausch + Lomb, Bausch & Lomb – Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P960022 | Class III | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
Sources (1)
- FDA PMA P960022 24 fields · synced Sep 18, 2026