Flourescein Sodium Ophthalmic Strips
by Ayerst Laboratories PMA
Active
PMA N17622
Overview
Fluorescein Sodium Ophthalmic Strips are diagnostic eye strips impregnated with fluorescein sodium, a bright yellow dye used to highlight corneal and tear film irregularities under blue light. These strips are intended for use in corneal injury detection, tear film diagnostics, and tonometry.
The strips are supplied in individually sealed pouches to ensure sterility and are packaged in boxes of 100. They are intended for single-use applications and should be stored in a cool, dry place away from direct light.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPCV | NumberN17622 | Date28 May 1976 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- PMA Number
- Advisory Committee
- Ophthalmic
- FDA Decision
- APCV
Questions
What is the primary use of Fluorescein Sodium Ophthalmic Strips in clinical practice?
Fluorescein Sodium Ophthalmic Strips are primarily used to detect corneal injuries and assess tear film irregularities. The bright yellow dye they contain highlights abnormalities under blue light, making it easier to identify issues like corneal scratches, ulcers, or dry eye conditions during eye examinations.
Are these strips reusable, or are they designed for single-use only?
These strips are explicitly intended for single-use applications. Each strip is individually sealed to maintain sterility, ensuring safe and hygienic use for one diagnostic procedure only.
How should Fluorescein Sodium Ophthalmic Strips be stored to maintain their effectiveness?
The strips should be stored in a cool, dry place away from direct light to preserve their integrity. Proper storage conditions help maintain the dye’s potency and prevent degradation, ensuring reliable performance when used.
What packaging format do these strips come in, and how many are included per box?
The strips are packaged in individually sealed pouches for sterility, and each box contains 100 strips. This format ensures easy access while maintaining the sterile condition of each strip until use.
How were these strips approved by the FDA, and what does that mean for clinicians?
These strips were approved through the FDA’s Premarket Approval (PMA) process, indicated by the PMA number (N17622). This means the FDA reviewed clinical data to confirm their safety and effectiveness for detecting corneal injuries and tear film abnormalities, giving clinicians confidence in their diagnostic reliability.