Identity
- Trade Name
- SENSITIVE EYES CHEMICAL DISINFECTANT FDA PMA
- Generic Name
- Accessories, soft lens products FDA PMA
Identifiers
- PMA Number
- P840020 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
- S003 (Normal 180 Day Track) FDA PMA
The Sensitive Eyes Chemical Disinfectant is an ophthalmic chemical disinfectant designed for use with soft contact lenses. Classified under accessories for soft lens products, it is intended to reduce microbial contamination on lenses to lower the risk of infection during wear.
This device is supplied as a liquid solution for manual application and is intended for single-use per manufacturer instructions. It is regulated under FDA PMA (P840020) and falls under the classification of Class II medical devices (LPN product code). Storage conditions and sterility are not specified in the provided data, but compliance with ophthalmic disinfection standards is implied for safe use.
Frequently asked questions
What is the Sensitive Eyes Chemical Disinfectant specifically designed for, and how does it help users?
The Sensitive Eyes Chemical Disinfectant is designed exclusively for soft contact lenses to reduce microbial contamination. By lowering the risk of infection during wear, it helps maintain lens hygiene and supports safe usage for individuals who wear soft contacts.
Is this product intended for reuse, or is it meant to be used once and then discarded?
The Sensitive Eyes Chemical Disinfectant is intended for single-use per the manufacturer’s instructions. This ensures proper disinfection without compromising sterility or effectiveness over repeated applications.
How is this product regulated, and what does that mean for its use in clinical settings?
This device is regulated under the FDA’s Premarket Approval (PMA) process, specifically under PMA number P840020, and classified as a Class II medical device. This means it has undergone rigorous review to ensure safety and effectiveness for its intended use as an ophthalmic chemical disinfectant for soft contact lenses.
Are there different sizes or models of this disinfectant available, or is it supplied in a single formulation?
The provided data lists multiple FEI numbers (e.g., 3006140792, 3012236936) under the product code LPN, which may indicate variations in formulation, packaging, or batch sizes. However, the core function remains consistent as a chemical disinfectant for soft contact lenses. For exact specifications, refer to the manufacturer’s labeling or documentation.
What should clinicians or users know about storing this product to maintain its effectiveness?
While specific storage conditions like temperature or light exposure aren’t detailed in the provided data, the product is designed for ophthalmic use, implying adherence to standard disinfection protocols. Users should follow the manufacturer’s guidelines (likely included in packaging or instructions) to preserve its efficacy, such as avoiding contamination or improper storage that could degrade its disinfectant properties.
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 | P840020 | Class II | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
Sources (1)
- FDA PMA P840020 23 fields · synced Sep 18, 2026