Durasoft Contact Lens

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

Generic Name

Lenses, soft contact, daily wear

PMA Number

N17852 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S002

• Gentle Touch UV (Netrafilcon A) Soft Contact Lenses

  Class II

  FDA 510(k) K991000 Active Cleared 28 Jun 1999

• Durasoft 2 (Phemfilcon a) Optifit Toric (Hydrophilic) Contact Lenses, Durasoft 2 (Phemfilcon a) Sherical ( Hydrophilic)C

  Class II

  FDA 510(k) K000439 Active Cleared 20 Mar 2000

• Prosoft (Phemfilcon) Soft (Hydrophilic) Contact Lens

  Class II

  FDA 510(k) K994335 Active Cleared 20 Mar 2000

• Durasoft 3 UV (Phemfilcon a) Optifit Toric (Hydrophilic) Contact Lenses, Durasoft 3 UV (Phemfilcon a) Spherical (Hydropi

  Class II

  FDA 510(k) K993935 Active Cleared 21 Dec 1999

• Precision UV (Vasurfilcon a)

  Class II

  FDA 510(k) K982988 Active Cleared 6 Jan 1999

• Durasoft Freshlook UV Colors; Durasoft 3 Freshlook UV Lite Tint

  Class II

  FDA 510(k) K954603 Active Cleared 4 Jan 1996

See all devices from Wesley Jessen Corp. →

• Are the Durasoft Contact Lenses designed for reuse, or are they intended for single-use only? Why?

  The Durasoft Contact Lenses are explicitly designed for single-use or daily wear, meaning each lens is intended for one-time use per wearer. This is supported by the product description, which states they are supplied in sterile packaging for direct application without reuse. The lack of any mention of reusable specifications or reprocessing instructions in the regulatory data further confirms this.

• What materials are the Durasoft Contact Lenses made from, and how does this affect their use?

  The Durasoft Contact Lenses are made from a hydrophilic polymer material, which provides comfort during wear and allows for oxygen permeability. This design supports corneal health by enabling adequate oxygen flow to the eye, making them suitable for extended daily use while maintaining comfort.

• How should I store the Durasoft Contact Lenses to ensure they remain sterile and intact?

  Storage instructions are not explicitly detailed in the provided data, but the lenses are supplied in sterile packaging for direct application. To maintain sterility and integrity, follow the manufacturer’s guidelines (Wesley Jessen Corp.) for storage, such as keeping them in a clean, dry environment away from direct sunlight or extreme temperatures until use.

• What regulatory pathway was followed for the approval of the Durasoft Contact Lenses, and what class does this device fall under?

  The Durasoft Contact Lenses were approved through the FDA Premarket Approval (PMA) process, as indicated by the `FDA_PMA` authorization. They are classified under Device Class II with the product code `LPL`, which aligns with soft contact lenses intended for corneal or scleral placement.

• Are there multiple sizes or models of the Durasoft Contact Lenses, or is this a single standardized product?

  The provided data lists multiple FEI numbers (Foreign Entity Identification numbers), which typically correspond to different lot or batch identifiers rather than distinct sizes or models. However, the description does not specify variations in curvature, diameter, or power. For precise sizing options, refer to the manufacturer’s catalog or product documentation, as the regulatory data does not detail individual lens specifications beyond the general classification as soft contact lenses for daily wear.