Airlens(R) (Airfocon a) Contact Lens Blue & Clear

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

Generic Name

Lens, contact (polymethylmethacrylate)

PMA Number

P830070 ↗

FDA Product Code

HPX

Device Class

U

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S002

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See all devices from Ciba Vision Corporation →

• Are these contact lenses reusable, or are they meant to be used only once per patient?

  The AirLens (AirFocon A) contact lenses are explicitly labeled as single-use disposable devices. This means each lens is intended for one-time use per patient and should not be reused, aligning with standard clinical practice for disposable contact lenses.

• What are the primary uses for the AirLens (AirFocon A) contact lenses, and how are they applied?

  These lenses are designed for ophthalmic use to either correct refractive errors or provide therapeutic coverage of the eye, with applications on the cornea or sclera. They are intended for professional fitting and use in clinical settings, ensuring proper placement and care by trained practitioners.

• How should the AirLens (AirFocon A) contact lenses be stored, and what precautions should be taken?

  While specific storage instructions aren’t detailed in the provided data, as a single-use disposable PMMA contact lens, they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow manufacturer guidelines for handling to maintain sterility and integrity before use.

• What regulatory pathway was followed for approval of the AirLens (AirFocon A) contact lenses, and what does that mean for clinicians?

  The AirLens (AirFocon A) lenses were approved through the FDA’s Premarket Approval (PMA) process, indicated by PMA number P830070. This means the device underwent rigorous review by the FDA to ensure safety and effectiveness before clinical use, giving clinicians confidence in its regulatory standing for ophthalmic applications.