Ciba Vision Cleaner
PMA P890062
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP890062 | Date21 Mar 1991 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Accessories, soft lens products
- PMA Number
- FDA Product Code
- LPN
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5928
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
- PMA Supplement
- S003 (Normal 180 Day Track)
Overview
AI-generated summary, 18 Sep 2026
The Ciba Vision Cleaner is a soft lens accessory designed for cleaning and maintaining soft contact lenses. Classified under the nomenclature for accessories, soft lens products, it is intended to aid in the removal of deposits and proteins from lens surfaces to ensure proper hygiene and lens longevity.
This device is supplied as a single-use solution and is regulated under FDA Premarket Approval (PMA) with PMA number P890062. It is intended for use in ophthalmic settings and adheres to regulatory requirements outlined in 21 CFR 886.5928. The product is available in multiple reference codes and is supplied in sterile packaging for direct patient use.
Other devices from Ciba Vision Corporation
Questions
AI-generated answers, 18 Sep 2026
What is the Ciba Vision Cleaner specifically designed to do for soft contact lenses?
The Ciba Vision Cleaner is a single-use solution designed to clean and maintain soft contact lenses by removing deposits and proteins from their surfaces. This helps ensure proper hygiene and extends the lifespan of the lenses, making it ideal for regular lens care routines.
Is the Ciba Vision Cleaner intended for reuse, or is it meant to be used once and discarded?
The Ciba Vision Cleaner is explicitly supplied as a single-use solution, meaning each package is intended for one-time use only. This design ensures optimal hygiene and prevents cross-contamination between uses.
How is the Ciba Vision Cleaner packaged, and is it sterile for direct patient use?
The Ciba Vision Cleaner comes in sterile packaging, which is designed for direct patient use. This ensures the solution remains uncontaminated before opening, maintaining its effectiveness and safety for cleaning lenses.
What regulatory pathway does the Ciba Vision Cleaner follow, and what does this mean for its use?
The Ciba Vision Cleaner follows the FDA Premarket Approval (PMA) pathway, with PMA number P890062. This means the device has undergone rigorous review by the FDA to ensure its safety and effectiveness for its intended use as a cleaning solution for soft contact lenses, adhering to the regulatory requirements outlined in 21 CFR 886.5928.
Are there multiple versions or sizes of the Ciba Vision Cleaner available, and how can I identify them?
Yes, the Ciba Vision Cleaner is available in multiple reference codes, as indicated by the various FEI numbers and registration numbers listed in the regulatory records. These codes help identify different versions or variants of the product, though the core function remains consistent across all versions—cleaning and maintaining soft contact lenses.