Aquify Lens Comfort Drops

• • Terminated Z-0182-06 FDA Unclassified (pre-2012) ·initiated 2 Nov 2005

  Lack of assurance of sterility at the time of manufacture.

510(k) Number

K013204 ↗

FDA Product Code

MRC

Device Class

Class II

Regulation

21 CFR Part 886.5918

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Focus Dailies Visitint (Nelfilcon a) One-Day Contact Lens

  Class II

  FDA 510(k) K984273 Active Cleared 25 Jan 1999

• Aquify Lens Comfort Drops

  Class II

  FDA 510(k) K042176 Active Cleared 3 Nov 2004

• Glitter Eyes (Tefilcon) Soft (Hydrophilic) Contact Lens for Daily Wear

  Class II

  FDA 510(k) K003071 Active Cleared 13 Dec 2000

• Aosept Plus Cleaning and Disinfecting Solution

  Class II

  FDA 510(k) K003345 Active Cleared 26 Mar 2001

• Aosept Clear Care Cleaning and Disinfecting Solution

  Class II

  FDA 510(k) K023455 Active Cleared 28 Feb 2003

• Modification to Karats Multi-Purpose Solution

  Class II

  FDA 510(k) K031957 Active Cleared 14 Aug 2003

See all devices from Ciba Vision Corporation →

• What is Aquify Lens Comfort Drops used for?

  Aquify Lens Comfort Drops is designed specifically for rigid gas permeable (RGP) contact lenses. It provides lubrication and moisture retention to alleviate dryness and irritation caused by lens wear. The formula includes sodium hyaluronate, which mimics natural tear behavior to enhance comfort for extended wear.

• How is Aquify Lens Comfort Drops supplied and intended for use?

  The product comes as a 10 mL solution in a dropper bottle. It is formulated for single-use per application—each dropper cap is meant for one-time use only. The solution is applied directly to the lens to ensure proper hydration and comfort without requiring sterilization or reuse.

• Is Aquify Lens Comfort Drops sterile, and can it be reused?

  Aquify Lens Comfort Drops is not intended to be sterile for clinical procedures. It is formulated for direct application to contact lenses and is designed for single-use per dropper. Reuse is not recommended, as it could compromise the product’s efficacy and hygiene.

• What regulatory classification and approval does Aquify Lens Comfort Drops hold?

  Aquify Lens Comfort Drops is classified as a Class II medical device under FDA regulations and holds a 510(k) clearance (K013204). This classification and approval are based on its intended use as a contact lens care product for rigid gas permeable lenses, adhering to FDA standards under regulation number 886.5918.

• How should Aquify Lens Comfort Drops be stored?

  While specific storage instructions are not detailed in the provided data, standard practices for eye drops recommend storing the product in a cool, dry place away from direct sunlight. Ensure the dropper cap is tightly sealed when not in use to maintain sterility and prevent contamination.