Allergan(R) Hydrocare(R) Clean & Disinfect Solutio

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

Softlens Cleaning and Soaking Sol.

Generic Name

Accessories, soft lens products

PMA Number

N17786 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S003

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See all devices from Advanced Medical Optics, Inc. →

• What is the primary purpose of the ALLERGAN® HYDROCARE® CLEAN & DISINFECT SOLUTION, and how does it differ from other contact lens care solutions?

  The ALLERGAN® HYDROCARE® CLEAN & DISINFECT SOLUTION is specifically designed to clean and disinfect soft contact lenses, ensuring they are free from contaminants and safe for wear. Unlike some solutions that may only clean or rinse lenses, this product combines both cleaning and disinfection in one formulation, which is particularly useful for maintaining lens hygiene in both clinical and home settings.

• Is this solution intended for single-use or reusable applications, and how should it be stored?

  The ALLERGAN® HYDROCARE® CLEAN & DISINFECT SOLUTION is supplied as a sterile solution, but whether it is intended for single-use or reusable depends on the specific formulation and manufacturer instructions. For optimal use, it should be stored according to the manufacturer’s guidelines, which likely include keeping it in a cool, dry place away from direct sunlight and ensuring the packaging remains unopened until use to maintain sterility.

• What regulatory pathway does this product follow, and what does that mean for its use in clinical settings?

  This solution follows the FDA’s Premarket Approval (PMA) pathway, authorized under PMA number N17786 and regulated under regulation number 886.5928. This means the product has undergone rigorous review to ensure its safety and effectiveness for cleaning and disinfecting soft contact lenses, making it suitable for use in both clinical and home environments as intended by the manufacturer.

• Are there different sizes or models of this solution available, and how would I know which one to choose?

  The provided data lists multiple FEI numbers (e.g., 3010607087, 1610287), which indicate different product variants or formulations of the ALLERGAN® HYDROCARE® CLEAN & DISINFECT SOLUTION. These variations may correspond to different package sizes, concentrations, or formulations (e.g., single-use vs. reusable). To determine the correct model, refer to the manufacturer’s instructions or consult with a supplier, as the choice depends on clinical or home use preferences and specific lens care needs.

• How does the advisory committee classification (OP) and medical specialty description (Ophthalmic) impact the use of this product?

  The advisory committee classification (OP) and medical specialty description (Ophthalmic) indicate that this product is specifically reviewed and approved within the ophthalmic domain by the FDA. This classification ensures that the solution meets the standards required for safe and effective use in eye care, reinforcing its suitability for cleaning and disinfecting soft contact lenses in professional and patient settings. It does not change the product’s intended use but confirms its regulatory alignment with ophthalmic practices.