Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft Contact Lenses
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- Bausch + Lomb Ultra (samfilcon A) Contact Lenses FDA PMA
- Generic Name
- Lenses, soft contact, extended wear FDA PMA
Identifiers
- PMA Number
- P170035 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 Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft Contact Lenses are hydrophilic, extended-wear soft contact lenses designed for refractive ametropia correction. These lenses address myopia, hyperopia, presbyopia, and astigmatism up to 5.00 diopters, with visibility tinting for easier handling and placement. They are intended for aphakic and non-aphakic individuals with non-diseased eyes, where astigmatism does not impair visual acuity.
These lenses are supplied as single-use or reusable, depending on the specific prescription, and are intended for extended wear up to 7 days between removals for cleaning, disinfection, or disposal as recommended by an eye care practitioner. They are classified as Class III devices under FDA regulations and are authorized under PMA (P170035). Storage and handling must comply with manufacturer guidelines to maintain sterility and performance.
Frequently asked questions
What vision conditions can the Bausch + Lomb Ultra Visibility Tinted Soft Contact Lenses correct, and what are the limitations for astigmatism?
These lenses are designed to correct myopia (nearsightedness), hyperopia (farsightedness), presbyopia (age-related near vision loss), and astigmatism. For astigmatism correction, the lenses are approved for up to **5.00 diopters**, but only if the astigmatism does not impair visual acuity. For presbyopia, add powers range from **+0.75D to +5.00D**. The lenses are intended for aphakic (without a lens) and non-aphakic individuals with non-diseased eyes.
Are these lenses single-use or reusable, and how often should they be removed for cleaning or disposal?
The Bausch + Lomb Ultra Visibility Tinted Soft Contact Lenses can be supplied as **single-use or reusable**, depending on the prescription. They are authorized for **extended wear up to 7 days** between removals for cleaning, disinfection, or disposal, as directed by an eye care practitioner. Removal frequency ensures proper hygiene and lens performance.
What special features do these lenses have to make them easier to handle, and how does that affect their use?
These lenses include a **visibility tint**, which makes them easier to see and handle during insertion and removal. This tint does not affect vision correction but improves usability, particularly for patients or practitioners who may struggle with transparent lenses.
What regulatory pathway was followed for approval of these lenses, and what class are they classified under?
The Bausch + Lomb Ultra Visibility Tinted Soft Contact Lenses were approved through the **FDA’s Premarket Approval (PMA) pathway** under PMA number **P170035**. They are classified as **Class III devices**, which requires rigorous pre-market approval due to their direct contact with the eye and extended wear capability.
How should these lenses be stored to maintain sterility and performance?
While the data does not specify exact storage instructions, the manufacturer’s guidelines must be followed to ensure **sterility and performance**. Typically, extended-wear contact lenses like these should be stored in a clean, dry environment, away from direct sunlight or extreme temperatures, and in their original packaging until use. Always adhere to the eye care practitioner’s recommendations for optimal handling.
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 | P170035 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
- FDA Applicant
- Bausch and Lomb, Inc.,
Sources (1)
- FDA PMA P170035 24 fields · synced Sep 18, 2026