Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (Hydrophilic) Contact Lens for Daily Wear

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

510(k) Number

K223585 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily;Eye Secret 38 UV Aspheric Color(polymacon) 1-Day Soft(hydrophilic) Contact Lens

  Class II

  FDA 510(k) K143052 Active Cleared 16 Dec 2014

• Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens

  Class II

  FDA 510(k) K151586 Active Cleared 10 Aug 2015

• Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear

  Class II

  FDA 510(k) K213983 Active Cleared 2 Sep 2022

• Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear

  Class II

  FDA 510(k) K150630 Active Cleared 15 Jun 2015

• Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear

  Class II

  FDA 510(k) K232839 Active Cleared 16 Dec 2024

• Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens

  Class II

  FDA 510(k) K143190 Active Cleared 16 Jan 2015

See all devices from Yung Sheng Optical Co., Ltd. →

• What is the Pure Plus UV Aspheric contact lens designed for?

  This lens is specifically designed to correct refractive ametropia—such as myopia (nearsightedness) or hyperopia (farsightedness)—in individuals with healthy eyes, including both aphakic (without a natural lens) and non-aphakic patients. Its aspheric optics enhance visual clarity, while the Otufilcon A silicone hydrogel material ensures comfort for extended daily wear.

• How is the Pure Plus UV Aspheric contact lens supplied and intended for use?

  The lens is supplied as a single-use product, meaning each lens is sterile and intended for one day of wear only. After use, it should be discarded to maintain hygiene and prevent contamination. This design aligns with FDA guidelines for daily-wear soft contact lenses, ensuring safety and convenience for users.

• Is the Pure Plus UV Aspheric contact lens reusable, or is it meant for single-use?

  This lens is exclusively for single-use only. It is not designed for reuse or disinfection. The sterile packaging ensures safety for one day of wear, after which the lens must be removed and discarded. Reusing contact lenses increases the risk of infection and complications, which is why single-use is strongly recommended.

• What storage conditions are required for the Pure Plus UV Aspheric contact lens?

  The lens must be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Exposure to moisture, heat, or UV light can compromise sterility and material integrity. Always check the packaging for expiration dates before use.

• Does the Pure Plus UV Aspheric contact lens have any special regulatory or safety considerations?

  The lens is classified as a Class II medical device under FDA regulations and holds a 510K clearance for ophthalmic use. While it includes UV-blocking properties for ocular protection, there are no specific MRI safety restrictions mentioned. Always follow FDA guidelines (regulation number 886.5925) and consult a healthcare provider for personalized advice, especially if considering alternative treatments or procedures.