Porofocon B Contact Lens

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

Full name

Cabcurve Contact Lens (Porofocon B)

Trade Name

Cabcurve (Porofocan B)

Generic Name

Lens, contact (polymethylmethacrylate)

PMA Number

N18032 ↗

FDA Product Code

HPX

Device Class

U

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S006

• 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 is the CABCURVE Contact Lens (Porofocon B) primarily used for in clinical practice?

  The CABCURVE Contact Lens (Porofocon B) is designed specifically for corneal reshaping or vision correction. It is a rigid gas-permeable contact lens made from polymethylmethacrylate (PMMA), intended to be professionally fitted by eye care practitioners for patients requiring these types of ophthalmic interventions.

• Is the CABCURVE Contact Lens (Porofocon B) intended for single-use or reusable applications, and how should it be stored?

  The CABCURVE Contact Lens (Porofocon B) is supplied in a sterile, single-use format. To maintain sterility and performance, it must be handled and stored strictly according to the manufacturer’s guidelines, which likely include keeping it in its original packaging until use and avoiding contamination.

• What regulatory pathway was followed for the approval of the CABCURVE Contact Lens (Porofocon B), and what does this mean for its use?

  The CABCURVE Contact Lens (Porofocon B) was approved through the FDA’s Premarket Approval (PMA) process, specifically under PMA N18032. This means the device underwent rigorous review by the FDA to ensure safety and effectiveness for its intended use in corneal reshaping or vision correction, and it is legally required to be used only as authorized by the approval.

• Are there different sizes or models available for the CABCURVE Contact Lens (Porofocon B), and how would a clinician determine the correct fit?

  While the provided data does not specify exact sizes or models, the CABCURVE Contact Lens (Porofocon B) is categorized under product code HPX and is intended for professional fitting by eye care practitioners. Clinicians would use standard ophthalmic measurements and fitting protocols to determine the appropriate lens parameters for each patient, ensuring optimal vision correction or corneal reshaping.