Horizon System

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

Full name

The Horizon System

Generic Name

Accessories, soft lens products

PMA Number

P810009 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S005

• What is the primary purpose of the Horizon System in ophthalmic care, and how does it differ from standard lens cases?

  The Horizon System is designed as a Soft Lens Product Accessory to support the handling, storage, and maintenance of soft contact lenses, ensuring proper care and hygiene for wearers. Unlike basic lens cases, it includes a full system of components—such as specialized cases, solutions, and related accessories—to enhance lens longevity and reduce contamination risks. This system is regulated under FDA Premarket Approval (PMA P810009) as a Class II medical device, reflecting its role in maintaining lens integrity and eye safety.

• Is the Horizon System available in reusable or single-use options, and how should I determine which variant is best for my practice?

  The Horizon System is supplied either as reusable or single-use, depending on the specific components included in the set. Reusable versions are designed for repeated use with proper cleaning and disinfection, while single-use variants minimize cross-contamination risks by being discarded after one use. The choice depends on your practice’s hygiene protocols, patient volume, and cost considerations—single-use may be preferred for high-risk or clinical settings, whereas reusable systems could suit bulk or office-based use with rigorous maintenance.

• Are there specific storage requirements for the Horizon System components, and how should they be handled to maintain efficacy?

  While the provided data does not specify sterility or MRI safety details, standard best practices for soft lens accessories recommend storing the Horizon System in a cool, dry place, away from direct sunlight or extreme temperatures. Reusable components should be cleaned and disinfected per manufacturer guidelines before reuse, and single-use items should be opened only in a sterile field to prevent contamination. Always follow the included instructions for optimal performance and compliance with ophthalmic hygiene standards.

• What regulatory pathway does the Horizon System follow, and how does this impact its use in clinical settings?

  The Horizon System is regulated under FDA Premarket Approval (PMA P810009) and classified as a Class II medical device under product code LPN (Lens Products, Non-Powered). This means it has undergone rigorous review by the FDA to ensure safety and effectiveness for its intended use—supporting soft contact lens care. Clinicians should confirm compatibility with their practice’s protocols and adhere to the approved labeling, as deviations could impact regulatory compliance or patient safety.