Oxysept System

No FDA recalls found in the data synced 6 Oct 2026.

Generic Name

Accessories, soft lens products

PMA Number

P850088 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S001 (THIRTY DAY TRACK)

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See all devices from Advanced Medical Optics, Inc. →

• What is the Oxysept System designed to do for soft contact lenses and how does it differ from traditional lens cases?

  The Oxysept System is specifically designed to clean, disinfect, and store soft contact lenses simultaneously, using a multi-chambered case combined with a proprietary disinfectant solution. Unlike traditional lens cases, it integrates the disinfectant directly into the storage process, ensuring lens hygiene and integrity during overnight or extended storage. The system emphasizes single-use per lens, with reusable cases and disposable components to maintain sterility.

• Is the Oxysept System intended for reuse or single-use, and what does that mean for the disinfectant solution?

  The Oxysept System is designed for single-use per lens, meaning each lens should be stored in a fresh, sterile solution chamber within the reusable case. The disinfectant solution itself is provided in sterile packaging, ensuring it remains uncontaminated for each use. The reusable case itself is meant to be cleaned and reused, but the disposable components (like the solution chamber) are replaced after each use to maintain hygiene.

• How is the Oxysept System regulated, and what does that mean for clinicians or buyers?

  The Oxysept System is classified as a Class II medical device under FDA regulations and is authorized through a Premarket Approval (PMA) with the number P850088. This means it has undergone rigorous clinical evaluation to ensure safety and effectiveness for its intended use. The system also complies with 21 CFR 886.5928, which governs ophthalmic accessories like soft lens products. Buyers and clinicians can rely on this regulatory pathway as evidence of the device’s compliance with FDA standards.

• Are there different sizes or models of the Oxysept System, and how do I know which one to choose?

  The Oxysept System is designed as a universal solution for soft contact lenses, meaning it is not specified with multiple sizes or models in the provided data. It is intended to accommodate standard soft contact lens sizes. Since it is a single-use system per lens, the choice typically depends on whether you need a reusable case with disposable solution chambers for one or multiple lenses. Always follow the manufacturer’s instructions to ensure proper use.

• How should the Oxysept System be stored, and what precautions should be taken to maintain its effectiveness?

  The Oxysept System should be stored in a cool, dry place, away from direct sunlight and extreme temperatures, to preserve the integrity of the disinfectant solution and reusable case. The sterile packaging of the disposable components must remain unopened until use to prevent contamination. Since the system relies on a proprietary disinfectant, avoid exposing it to moisture or chemicals that could degrade its effectiveness. Always follow the manufacturer’s storage guidelines to ensure optimal performance.