Weicon (Tefilicon) Hydrophilic Contact Lens

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

Full name

Weicon (R) (Tefilicon) Hydrophilic Contact Lens

Generic Name

Lenses, soft contact, daily wear

PMA Number

P810005 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S014

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• Are these contact lenses designed for overnight wear, or are they meant to be removed at night like daily-wear lenses typically are?

  The Weicon (Tefilicon) Hydrophilic Contact Lens is explicitly classified as a daily-wear device, meaning it is intended for short-term use and should be removed at night. This design aligns with its FDA_PMA approval (P810005) under product code LPL, which specifies it is not for continuous or extended wear.

• How are these lenses supplied, and what should I know about their sterility and single-use nature?

  The Weicon (Tefilicon) Hydrophilic Contact Lens is supplied as a single-use, sterile product for ophthalmic use only. Each lens is intended for one-time wear and disposal, ensuring hygiene and reducing the risk of infection. The sterility is maintained through manufacturing controls, but no specific storage instructions (e.g., refrigeration or expiration) are provided in the data.

• Are there multiple sizes or models available for this contact lens, and how would I determine the correct fit?

  While the data lists numerous registration numbers (e.g., 3015533540), these are administrative identifiers and do not directly indicate specific sizes or models. The lens is designed for corneal or scleral placement to correct refractive errors, so the correct fit would be determined by an eye care practitioner during a professional fitting, as required by the device’s intended use.

• What regulatory pathway was followed for this device’s approval, and what does that mean for clinicians or buyers?

  The Weicon (Tefilicon) Hydrophilic Contact Lens was approved through the FDA’s Premarket Approval (PMA) process, indicated by the PMA number P810005 and product code LPL. This pathway ensures rigorous evaluation of safety and effectiveness for Class II devices, meaning clinicians and buyers can rely on established standards for performance and compliance with 21 CFR 886.5925. The approval does not imply overnight wear but confirms suitability for daily use.