Ciba Vision Lens Drops
PMA P860060
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP860060 | Date8 Aug 1988 | 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- Withdrawn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
- S001 (Normal 180 Day Track)
Overview
AI-generated summary, 18 Sep 2026
This device is classified as Accessories, Soft Lens Products and is designed for use with soft contact lenses. It provides a sterile solution for cleaning, disinfecting, storing, and rinsing soft contact lenses to maintain hygiene and lens integrity.
The Lens Drops are supplied as a sterile, single-use solution and are intended for ophthalmic use. They are regulated under FDA_PMA with approval number P860060 and fall under device class 2 with regulation number 886.5928. Multiple registration numbers and FEI numbers are associated with this product, indicating various formulations or variants.
Other devices from Ciba Vision Care
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of CIBA VISION LENS DROPS and how does it differ from traditional contact lens solutions?
CIBA VISION LENS DROPS are designed specifically for cleaning, disinfecting, storing, and rinsing soft contact lenses to ensure hygiene and maintain lens integrity. Unlike traditional multi-purpose solutions, these are supplied as a sterile, single-use solution, which reduces the risk of contamination from repeated use of the same bottle. They are intended exclusively for ophthalmic use with soft contact lenses.
Are CIBA VISION LENS DROPS reusable, or are they meant for single-use only?
CIBA VISION LENS DROPS are explicitly labeled as a sterile, single-use solution. This means each drop is intended for one-time use on a contact lens, minimizing the risk of microbial buildup or cross-contamination that can occur with reusable solutions. The single-use format aligns with best practices for maintaining lens hygiene.
What regulatory pathway does CIBA VISION LENS DROPS follow, and what does this mean for clinicians or buyers?
CIBA VISION LENS DROPS are regulated under the FDA’s Premarket Approval (PMA) pathway, with approval number P860060. This classification (Device Class 2, regulation number 886.5928) indicates that the product has undergone rigorous review to ensure safety and effectiveness for its intended use—cleaning, disinfecting, and storing soft contact lenses. Clinicians or buyers can rely on this approval as evidence of the product’s compliance with FDA standards.
How many different formulations or variants of CIBA VISION LENS DROPS exist, and what does this mean for compatibility with contact lenses?
CIBA VISION LENS DROPS includes multiple FEI (Final Establishment Identification) numbers, indicating several distinct formulations or variants. These variants may differ in composition or intended use (e.g., for specific lens materials or patient needs). Buyers or clinicians should verify compatibility with their patients’ contact lens type or prescription, as not all variants may be suitable for every lens. The manufacturer’s labeling or product documentation should specify which variant is appropriate.
What storage requirements should be followed for CIBA VISION LENS DROPS to maintain sterility and effectiveness?
While the data does not specify exact storage conditions, as a sterile, single-use solution, CIBA VISION LENS DROPS should be stored in a cool, dry place away from direct sunlight and extreme temperatures to preserve sterility and efficacy. Unopened drops should be kept in their original packaging until use, and any unused drops should be discarded after application to avoid contamination. Always follow the manufacturer’s instructions on the packaging for optimal storage.