Identity
- Trade Name
- B&L SENSITIVE EYES(TM) DAILY CLEANER FDA PMA
- Generic Name
- Accessories, soft lens products FDA PMA
Identifiers
- PMA Number
- P830013 FDA PMA
- FDA Product Code
- LPN FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 886.5928 FDA PMA
- Regulation Number
- 886.5928 FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
- PMA Supplement
- S001 (Normal 180 Day Track) FDA PMA
The B&L Sensitive Eyes Daily Cleaner is a soft lens accessory designed for cleaning and maintaining contact lenses. Classified under ophthalmic accessories, it is intended for daily use with soft contact lenses to ensure proper hygiene and care.
This product is supplied as a single-use solution and is regulated under FDA Premarket Approval (PMA P830013). It is intended for use in ophthalmic settings and adheres to regulatory standards outlined in 21 CFR 886.5928. The solution is packaged for individual use and requires no sterilization beyond its manufacturer-provided sterility assurance.
Frequently asked questions
What is the B&L Sensitive Eyes Daily Cleaner primarily used for in clinical practice?
The B&L Sensitive Eyes Daily Cleaner is designed exclusively for cleaning and maintaining soft contact lenses on a daily basis. It ensures proper hygiene and care for lenses, helping to reduce the risk of contamination and irritation. This makes it ideal for patients who wear soft lenses and require a gentle, single-use solution to preserve lens clarity and comfort.
Is the B&L Sensitive Eyes Daily Cleaner intended for reuse, or is it meant for single-use only?
The B&L Sensitive Eyes Daily Cleaner is explicitly supplied as a single-use solution, meaning each package is intended for one-time use only. This design eliminates the need for sterilization beyond the manufacturer’s built-in sterility assurance, ensuring consistent hygiene for each application.
How is the sterility of this product maintained, and do I need to perform additional sterilization steps?
The B&L Sensitive Eyes Daily Cleaner comes with manufacturer-provided sterility assurance, meaning no additional sterilization is required. The solution is packaged for individual use, and its sterility is preserved until the seal is broken. This ensures a clean, ready-to-use solution for each application without extra handling.
What regulatory pathway does this product follow, and how does that affect its use in clinical settings?
The B&L Sensitive Eyes Daily Cleaner is regulated under FDA Premarket Approval (PMA P830013), which means it has undergone rigorous review to ensure safety and effectiveness for its intended use. Clinically, this means it adheres to strict standards outlined in 21 CFR 886.5928, ensuring reliability and compliance with ophthalmic hygiene protocols. Its classification as a Class II device reflects its role as a critical accessory for soft lens care.
Are there multiple sizes or models of this product, or is it available in a single formulation?
The data provided does not specify variations in sizes or models for the B&L Sensitive Eyes Daily Cleaner, indicating it is likely offered in a standard single-use formulation designed for universal compatibility with soft contact lenses. If specific formulations or packaging sizes exist, they would be consistent with the manufacturer’s stated intent for daily cleaning and maintenance of soft lenses.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P830013 | Class II | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
Sources (1)
- FDA PMA P830013 23 fields · synced Sep 18, 2026