Soft Contact Lens

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

Generic Name

Lenses, soft contact, daily wear

PMA Number

N17987 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S002

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See all devices from Ciba Vision Corporation →

• Are these lenses designed for extended wear, or are they meant for daily use only?

  These lenses are explicitly labeled as ‘Daily Wear’, meaning they are intended for continuous wear only during the daytime and should not be worn overnight. The design prioritizes oxygen permeability to maintain corneal health while providing clear vision for daily activities, but they are not approved for extended or continuous wear.

• How are these lenses packaged and stored to ensure sterility and usability?

  The lenses are supplied sterile in individual blister packs, which protects them from contamination. Storage requires keeping them dry and away from moisture or direct sunlight, following the manufacturer’s guidelines to preserve sterility and performance. Avoiding exposure to humidity or extreme temperatures is critical for maintaining their integrity.

• Can these lenses be reused, or are they intended for single-use only?

  These lenses are intended for single-use or disposable applications, meaning each lens is designed for one-time wear and should not be reused. The packaging is structured to support this use pattern, ensuring hygiene and safety for each patient.

• What regulatory pathway was followed for approval, and how does that affect their use?

  The lenses received FDA Premarket Approval (PMA) under authorization N17987, which is the highest regulatory standard for medical devices in the U.S. This approval confirms their safety and effectiveness for corneal refractive correction as daily-wear soft contact lenses. The PMA process ensures rigorous evaluation, but it does not imply extended wear or other uses beyond what’s explicitly stated in the labeling.

• Are there multiple sizes or models available, and how do I determine the right fit?

  While the data includes multiple registration numbers and product codes (e.g., LPL), these typically correspond to variations in design, material, or prescription rather than physical sizing. The correct fit depends on a patient’s prescription, corneal curvature, and eye health, which should be assessed by an eye care professional. The manufacturer likely offers a range of diopters and base curves to accommodate different needs.