N-18 (Kolfocon a), N-32 (Kolfocon B) Lens Material

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

Generic Name

Lens, contact (other material) - daily

PMA Number

P880024 ↗

FDA Product Code

HQD

Device Class

Class II

Regulation

21 CFR Part 886.5916

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S003 (Normal 180 Day Track)

• Tyro-97 (Hofocon a), Onsi 56 (Hofocon), Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lens

  Class II

  FDA 510(k) K102154 Active Cleared 21 Jan 2011

• Onsi -56 (Onsifocon a) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lens

  Class II

  FDA 510(k) K033599 Active Cleared 16 Sep 2004

• Lsh (Mangofilcon a) Sphere Soft (Hydrophilic) Contact Lens, Lsh (Mangofilcon a) Multifocal Soft (Hydrophilic) Contact Le

  Class II

  FDA 510(k) K120756 Active Cleared 13 May 2013

• Progent Large Diameter Contact Lens Case for Rigid Gas Permeable Lens

  Class II

  FDA 510(k) K130285 Active Cleared 3 Apr 2013

• Tyro 97 (Hofocon a) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lenses for Daily Wear

  Class II

  FDA 510(k) K052507 Active Cleared 2 Nov 2005

• Are these materials intended for manufacturing reusable contact lenses, or are they specifically designed for single-use lenses only?

  These materials, N-18 (KOLFOCON A) and N-32 (KOLFOCON B), are explicitly formulated for single-use daily disposable contact lenses. The device description states they are designed for ‘daily’ ophthalmic applications, ensuring oxygen permeability and optical clarity for corneal refraction correction without implying reuse. The bulk components are supplied non-sterile for sterile, single-use lens production only.

• What are the key differences between the KOLFOCON A (N-18) and KOLFOCON B (N-32) formulations, and how might they impact lens performance?

  The N-18 (KOLFOCON A) and N-32 (KOLFOCON B) are distinct formulations of the same base material type (Lens, Contact – Other Material) but are not described as differing in clinical performance or oxygen permeability in the provided data. The distinction lies in their specific formulation codes, which may influence properties like water content, wettability, or mechanical durability for daily disposable lenses. For precise performance differences, consult manufacturer specifications or clinical studies referenced by The Lagado Corp.

• How are these materials regulated in the U.S., and what does the FDA Premarket Approval (PMA) cover for these bulk components?

  These materials are regulated under FDA Premarket Approval (PMA P880024) as Class II devices, complying with 21 CFR 886.5916 for ‘Lens, Contact (Other Material) – Daily.’ The PMA covers the bulk components supplied by The Lagado Corp., which are intended for sterile, single-use contact lens manufacturing. The approval does not apply to the final lens product but ensures the raw materials meet safety and performance standards for ophthalmic use when processed into daily disposable lenses.

• Are the bulk materials supplied sterile, or is sterilization part of the lens manufacturer’s process?

  The bulk materials (N-18 and N-32) are supplied non-sterile by The Lagado Corp. The device description explicitly states they are ‘intended for use in sterile, single-use contact lenses,’ meaning sterilization is the responsibility of the lens manufacturer during the lens production process. This aligns with the single-use design, where each lens is individually sterilized before patient use.

• What is the regulatory history or timeline for these materials, and how does the supplement (S003) affect their status?

  The original PMA (P880024) was approved on March 4, 1994, following a 180-day track normal supplement (S003) filed on March 5, 1993, for changes in design/components/specifications/material. The supplement indicates updates to the materials’ formulation or processing, but the core approval remains valid for the bulk components as ‘Lens, Contact (Other Material) – Daily.’ The timeline reflects a standard regulatory pathway for modifications to existing PMA-approved devices.