Technicon-38 (Polymacon) Hydrophylic Lenses

No FDA recalls found in the data synced 6 Oct 2026.

Generic Name

Lenses, soft contact, daily wear

PMA Number

P900065 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S001 (Normal 180 Day Track)

• Horizon 55 Bi-Con

  Class II

  FDA 510(k) K945365 Active Cleared 28 Dec 1994

• Horizon 55 Bi-Con Toric

  Class II

  FDA 510(k) K950818 Active Cleared 21 Mar 1995

• Horizon 59 Oasis (Hioxifilcon a) Daily Wear Contact Lenses

  Class II

  FDA 510(k) K043540 Active Cleared 1 Feb 2005

• Horizon/Westhin 38 Sofblu (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens (Tinted, Lathe-Cut From Lens Blan

  Class II

  FDA 510(k) K963837 Active Cleared 20 Dec 1996

• Horizon 38 (Clear) and Horizon 38 Westint (Tinted)

  Class II

  FDA 510(k) K023530 Active Cleared 26 Nov 2002

• Horizon (Methafilcon a) Daily Wear Sphere and Toric Contact Lenses

  Class II

  FDA 510(k) K031774 Active Cleared 20 Feb 2004

See all devices from Westcon Contact Lens Co., Inc. →

• Are these lenses intended for overnight wear, or are they strictly for daily use during waking hours?

  The Technicon-38 (Polymacon) Hydrophilic Lenses are explicitly designed for daily wear only, meaning they are intended to be worn during waking hours and removed before sleep. The product description and regulatory classification (daily wear soft contact lenses) confirm this use case, so they are not approved for continuous or extended overnight wear.

• How should these lenses be stored before use, and do they come pre-sterilized?

  These lenses are supplied as non-sterile single-use devices, so they must be handled according to clinical guidelines for contact lens care. Storage instructions are not detailed in the provided data, but standard practice for non-sterile contact lenses includes storing them in a clean, dry environment away from direct sunlight or moisture until use. Always follow manufacturer-provided instructions or clinical protocols for proper preparation.

• Can these lenses be reused after a single application, or are they meant to be discarded after one use?

  The Technicon-38 (Polymacon) Hydrophilic Lenses are explicitly labeled as single-use, meaning they are designed for one-time application only. After removal, they should be discarded according to clinical waste disposal guidelines. Reuse is not recommended or supported by the manufacturer or regulatory classification.

• What regulatory pathway was followed for approval, and how does this affect their use in clinical settings?

  These lenses were approved through the FDA Premarket Approval (PMA) pathway, specifically under PMA number P900065. This indicates a rigorous review process for devices deemed to have higher risk or novel features. Clinically, this means the lenses meet FDA standards for safety and effectiveness as daily-wear soft contact lenses, but practitioners should still adhere to standard of care protocols for fitting, follow-up, and patient education.