Polycon Contact Lens

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

Trade Name

Polycon Hard Contact Lense

Generic Name

Lens, contact (polymethylmethacrylate)

PMA Number

N18120 ↗

FDA Product Code

HPX

Device Class

U

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. →

• What types of vision correction does the Polycon Contact Lens specifically address, and why is its rigid design beneficial for this purpose?

  The Polycon Contact Lens is designed for corneal refractive correction, meaning it directly addresses vision issues caused by irregularities on the eye’s surface, such as keratoconus or astigmatism. Its rigid polymethylmethacrylate (PMMA) construction ensures stability and precision optical alignment, which is critical for maintaining clear vision over extended periods. The rigid design also reduces movement on the eye, improving comfort and accuracy for long-term wear.

• How should the Polycon Contact Lens be handled to ensure proper sterility and integrity before use, especially if it’s being reused?

  The Polycon Contact Lens can be used either as a single-use or reusable device, depending on clinical protocols. If reused, it must undergo proper sterilization or disinfection between uses to prevent contamination. Storage must strictly follow manufacturer guidelines to preserve sterility and structural integrity, as improper handling could compromise the lens’s performance or safety.

• Are there different sizes or models available for the Polycon Contact Lens, and how might a clinician determine the appropriate fit for a patient?

  The Polycon Contact Lens comes in multiple models, as indicated by the FEI numbers (e.g., 3002807465, 3002340631), which likely correspond to variations in diameter, base curve, or other fitting parameters. A clinician would determine the correct size and model based on the patient’s corneal curvature, refractive error, and ocular health, ensuring optimal vision correction and comfort. Consulting the manufacturer’s sizing charts or fitting guides is essential for accurate selection.

• What storage conditions are necessary to maintain the Polycon Contact Lens in its intended condition before use?

  The Polycon Contact Lens must be stored according to the manufacturer’s guidelines to preserve sterility and structural integrity. This typically includes keeping it in a clean, dry environment away from direct sunlight, extreme temperatures, or moisture. Proper packaging should remain unopened until use, and any reusable lenses must be stored in a sterile case or container designed for contact lenses to prevent contamination between uses.

• What regulatory pathway does the Polycon Contact Lens follow, and what does this mean for clinicians or facilities considering its use?

  The Polycon Contact Lens is regulated under the FDA’s Premarket Approval (PMA) pathway, with PMA number N18120 and product code HPX. This means its safety and effectiveness were thoroughly evaluated by the FDA before approval, ensuring it meets rigorous standards for use in corneal refractive correction. Clinicians or facilities must adhere to FDA-compliant protocols for handling, fitting, and patient care to maintain compliance and patient safety.