Softcon Bandage Lens

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

Generic Name

Lenses, soft contact, daily wear

PMA Number

N17375 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S004

• In a Wink Lubricating & Rewetting Drops

  Unclassified

  FDA 510(k) K853445 Active Cleared 29 Nov 1985

• Professional Disinfection System (Pds)

  Class II

  FDA 510(k) K863346 Active Cleared 27 Feb 1987

• Ciba Vision Lens Drops

  Class II

  FDA PMA P860060 Active Approved 8 Aug 1988

• Salt Tablets

  Class II

  FDA PMA P810015 Active Approved 6 Aug 1982

• Minitheerm Soft Contact Lenses

  Class II

  FDA PMA N18001 Active Approved 8 Aug 1979

• SoftCon (Vifilcon A) Soft Contact Corrective Lens

  Class II

  FDA PMA N17554 Active Approved 1 Jul 1985

See all devices from Ciba Vision Care →

• What is the primary purpose of the Softcon Bandage Lens, and how does it support eye recovery?

  The Softcon Bandage Lens is designed to provide therapeutic coverage and protection to the cornea, promoting healing after procedures like corneal surgery, trauma, or abrasions. Its soft, daily-wear material allows for oxygen permeability, ensuring the cornea remains stable and healthy while maintaining visual clarity during recovery. It is specifically intended for short-term therapeutic use under professional supervision.

• Are the Softcon Bandage Lenses single-use or reusable, and what does this mean for clinical workflow?

  The Softcon Bandage Lenses are supplied as single-use, sterile devices. This means each lens is intended for one patient only, reducing the risk of cross-contamination and ensuring hygiene. Clinically, this simplifies inventory management and eliminates the need for cleaning or sterilization between uses, streamlining workflow for therapeutic applications.

• How are the Softcon Bandage Lenses authorized for use, and what does this imply for prescribers?

  The Softcon Bandage Lenses hold FDA_PMA authorization (PMA N17375, Supplement S001), which means they have undergone rigorous review by the FDA for safety and effectiveness. This authorization implies that prescribers must adhere to the approved therapeutic indications—such as post-surgical corneal protection—and follow proper fitting and care protocols to ensure patient safety and efficacy.

• What sizes and prescriptions are available for the Softcon Bandage Lens, and how does this affect patient fitting?

  The Softcon Bandage Lenses are available in various sizes and prescriptions, allowing for customization to fit individual patient needs. This flexibility ensures that clinicians can select the appropriate lens to match the patient’s corneal curvature and refractive requirements, optimizing comfort and therapeutic outcomes during recovery.

• How should the Softcon Bandage Lenses be stored, and what precautions should be taken to maintain their sterility?

  As single-use, sterile devices, the Softcon Bandage Lenses must be stored in a clean, dry environment protected from contamination. The packaging should remain intact until use to preserve sterility. Clinicians should follow manufacturer guidelines for storage conditions, such as avoiding extreme temperatures or exposure to direct sunlight, to ensure the lenses remain viable for their intended therapeutic application.