Cornea Coat® Support

Download ui-60010-4-2006.pdf User Instructions

CORNEA COAT®
REF: 60010.000

Instructions For Use

Description: Cornea Coat® is a sterile, viscoelastic irrigating device to be used on the exterior cornea to prevent drying of the epithelial layer during ophthalmic surgical procedures. It is applied onto the anterior surface of the cornea where it forms a protective layer. It’s unique formula is designed to provide a controlled evaporation rate to remain on the cornea for up to 20 minutes, eliminating the need for repeated irrigation. It’s properties also allow it to adhere to the cornea and form a thin optically neutral clear film without changing the anterior curvature. It can be easily removed by simple irrigation with BSS.

Formula: Cornea Coat® is a physiologically balanced solution containing Hydroxypropylmethylcellulose.

Package: Cornea Coat® is individually packaged in a sterile syringe and peel pouch. A sterile 23 gauge cannula is also provided with each syringe.

Cautions: Check the integrity of the sterile pouch before use. Do not use if product appears damaged. Check expiration date on the pouch before use. Both syringe and cannula are for single use only.

Contraindications: There are no known contraindications at present.

Directions:

Circulating Nurse
1. Inspect package for damage. If packaging appears damaged, do not use this item.
2. Peel open the outer pouch and drop the Cornea Coat® syringe onto the sterile field.
3. Repeat steps 1 & 2 for the sterile cannula.
Operating Nurse
4. Remove the tip cap from the syringe by twisting and pulling it while holding the Luer lock.
5. Attach the cannula tightly to the Luer lock tip of the syringe.
6. Apply pressure to the plunger in order to expel air from the cannula and verify the proper operation of the syringe.

Surgeon/Operating Nurse
7. Thoroughly rinse the cornea to remove blood or other materials.
8. Using the syringe plunger slowly release a small amount of Cornea Coat® onto the center of the
cornea and allow it to flow and cover the entire surface.
9. Periodically check cornea to observe drying out of Cornea Coat®.
10. Reapply as needed
Sterilization: Cornea Coat® is sold sterile for single use only. After use it should be properly disposed of according to medical waste guidelines of your facility. If sterile
packaging is damaged, do not use this item.
Storage: Store between 5 and 50 degrees C. (41 to 122 F.)

FDA Listing

Download Cornea Coat® FDA Device Listing Page

Device Listing Database
Proprietary Device Name: CORNEA COAT IRRIGATION
DEVICE
Common/Generic Device
Name:
OCULAR SURGERY IRRIGATION
DEVICE
Classification Name: DEVICE, IRRIGATION, OCULAR
SURGERY
Device Class: 1
Product Code: KYG
Regulation Number: 886.4360
Medical Specialty: Ophthalmic
Owner/Operator: INSIGHT INSTRUMENTS, INC.
Owner/Operator Number: 1052234
Registered Establishment
Name: INSIGHT INSTRUMENTS, INC.
Establishment Registration
Number: 1052234
Date of Listing: 05/26/04
Listing Status: Active
Establishment Operations: Manufacturer, Specification
Developer