Miraflow Extra Strength Cleaner

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

Generic Name

Accessories, soft lens products

PMA Number

P850055 ↗

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 Ciba Vision Corporation →

• What is the Miraflow Extra Strength Cleaner primarily used for and in what clinical setting is it intended?

  The Miraflow Extra Strength Cleaner is designed specifically for cleaning soft contact lenses to remove deposits and maintain lens clarity. It is formulated to be compatible with various soft lens materials, making it suitable for use in ophthalmic settings such as eye care clinics, optometrist offices, and other professional environments where contact lens care is provided.

• Is the Miraflow Extra Strength Cleaner sterile, and how should it be used—single-use or multi-use?

  The Miraflow Extra Strength Cleaner is supplied as a non-sterile solution. Its usage—whether single-use or multi-use—depends on the manufacturer’s instructions, which must be followed carefully to ensure proper hygiene and effectiveness. Always refer to the labeling for specific guidance.

• What regulatory pathway was followed for the approval of this device, and what class does it fall under?

  The Miraflow Extra Strength Cleaner was approved through the FDA’s Premarket Approval (PMA) process under PMA number P850055. It is classified as a Class II medical device under the LPN (Lens Products, Non-Prescription) product code, indicating it is subject to special controls to ensure its safety and effectiveness.

• Are there specific storage conditions or shelf-life considerations mentioned for this cleaner?

  The storage conditions and shelf-life details are provided on the product labeling, as noted in the supplement for labeling changes. Since the device is regulated under FDA PMA, the manufacturer’s instructions on the packaging should be followed to maintain efficacy and ensure proper storage, including any temperature or light exposure guidelines.

• How can I verify if this cleaner is compatible with the specific type of soft contact lenses I use?

  The Miraflow Extra Strength Cleaner is formulated to be compatible with various soft lens materials, but the manufacturer’s instructions should always be consulted to confirm compatibility with your specific lens type. If in doubt, consult with an eye care professional or refer to the labeling for guidance on proper usage.