Ciba Vision Contact Lens Case

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

Full name

Ciba Vision(R) Contact Lens Case

510(k) Number

K943183 ↗

FDA Product Code

LRX

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

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• Modification to Karats Multi-Purpose Solution

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  FDA 510(k) K031957 Active Cleared 14 Aug 2003

See all devices from Ciba Vision Corporation →

• What are the key differences between single-use and reusable versions of this contact lens case, and how should I decide which to use?

  The CIBA VISION® Contact Lens Case is designed for both single-use and reusable storage of soft contact lenses. The choice depends on hygiene preferences and convenience. Single-use cases are ideal for minimizing contamination risk between wearings, while reusable cases are more cost-effective for long-term use if properly cleaned and disinfected according to manufacturer guidelines. Both versions provide a sterile, sealed environment to maintain lens hygiene, but single-use eliminates the need for cleaning between uses.

• Are there different sizes or configurations available for this contact lens case, and how do I know which one fits my lenses?

  Yes, the CIBA VISION® Contact Lens Case comes in multiple sizes and configurations to accommodate various lens types and brands. The design adheres to ophthalmic standards for lens care, ensuring compatibility with most soft contact lenses. To determine the right fit, check the manufacturer’s sizing guide or consult with your eye care professional, as some cases may include features like lens compartments or ventilation systems tailored to specific lens shapes or materials.

• How should I store this contact lens case to maintain its effectiveness and hygiene, especially if it’s a reusable model?

  For reusable cases, store the CIBA VISION® Contact Lens Case in a cool, dry place, away from direct sunlight or extreme temperatures. After each use, clean it thoroughly with contact lens solution (not tap water) and allow it to air-dry completely before reuse. Never store lenses in the case overnight without proper cleaning, as this can promote bacterial growth. Single-use cases should be discarded immediately after use to avoid contamination risks.

• What regulatory pathway was followed for this device, and how does that affect its safety and reliability?

  The CIBA VISION® Contact Lens Case received FDA 510(k) clearance under the Traditional pathway, with a decision code of *SESE* (Substantially Equivalent to a Predicate Device). This means it was determined to have the same intended use and technological characteristics as previously cleared contact lens cases, ensuring its safety and effectiveness through a rigorous review process by the FDA’s Ophthalmic (OP) Advisory Committee. The classification as a Class II medical device also indicates it undergoes additional manufacturing controls to maintain quality and performance.