Dry Eye Test

Fluorescein Sodium · Strip · Ophthalmic

Prescription (Rx) Diagnostic Dye 1 recall

Uses

For testing tear film stability by determining the fluorescein break-up time (FBUT).

Dosage and administration

Procedure for measuring Fluorescein Break-up Time (FBUT) with Amcon Dry Eye Test Strips. 1. Apply one or two drops of non-preserved saline to the impregnated paper tip. Excess fluid will automatically fall off. Shaking is neither required nor desirable. 2. Ask the patient to look down and in. 3. Gently touch the strip to the superior temporal bulbar conjunctiva for one or two seconds. 4. Ask the patient to blink three times and open eyes naturally. 5. Conduct the FBUT measurements immediately. 6. Perform two consecutive measurements. If not consistent, conduct a third and average the results. 7. Repeat steps 1 through 6 using a new strip for the second eye FBUT values of less than 10 seconds are considered abnormal. Values less than 5 seconds are indicative of dry eye disorder. Values of 5 to 9 seconds are borderline dry eye. NOTE: The contents may not be sterile if the individual strip package has been damaged or previously opened. This product is intended for external use only. Keep out of reach of children. Store below 30°C.

Contraindications

Hypersensitivity to components or mercury-containing compounds.

How supplied

Carton of 50 pouches of two strips each.

Label text from the FDA structured product label by Nomax Inc. (revised Dec 23, 2019). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Dry Eye Test NDC products (1)

NDCStrength & formLabelerType
51801-008Fluorescein Sodium .12 mg/1
Strip
Nomax Inc.UNAPPROVED DRUG OTHER

Dry Eye Test recalls

Frequently asked questions

What is Dry Eye Test used for?

For testing tear film stability by determining the fluorescein break-up time (FBUT).

Who makes Dry Eye Test?

Dry Eye Test is listed by 1 labeler in the FDA NDC directory, including Nomax Inc..

Has Dry Eye Test been recalled?

The FDA enforcement database lists 1 recall for Dry Eye Test, most recently D-0387-2021 (class iii): Subpotent Drug