Instructions for Use
Trans-Epithelial Kit
Riboflavin Solutions for Accelerated Corneal Cross-Linking
For epithelium-on procedure
Contents:•ParaCel Part 1 syringe and ophthalmic cannula – syringe filled with 1.8ml ParaCel Part 1•ParaCel Part 2 syringe and ophthalmic cannula – syringe filled with 2.0 ml ParaCel Part 2

Part 1
Composition:
0.25% Riboflavin
Benzalkonium Chloride
EDTA
Trometamol
Hydroxypropylmethylcellulosewith NaCl
Phosphate buffered saline solution

Part 2Composition:
0.22 % Riboflavinwith NaCl
Phosphate buffered saline solution

FOR SINGLE USE ONLYCharacteristics:
Riboflavin (vitamin B2) is a water-soluble yellow substance.

WARNING: USE ONLY ON INTACT EPITHELIUM
Usage:For surface applications:1.
Do not remove corneal epithelium.
2.
Place the patient in a supine position.
3.
Apply topical anaesthetic to the cornea.
4.
Apply a lid speculum using standard clinical techniques.
5.
Measure corneal thickness to ensure that it is greater than 325 µm.
6.
Apply sufficient ParaCel Part 1 (with purple plunger) to completely cover the cornea and repeat this procedure every
90 seconds for a total of 4 minutes.
7.
Rinse cornea completely with ParaCel Part 2 (with white plunger).
8.
Apply sufficient ParaCel Part 2 to completely cover the cornea and repeat this procedure every 90 seconds for a totalof 6 minutes.
9.
Initiate UV treatment using the KXL System at the completion of Step 8, applying a drop of BSS every 90 to 120
seconds during irradiation.
10. Rinse cornea completely with BSS.
11. Remove speculum using standard clinical techniques.
12. Advise patient to refrain from eye rubbing.
Indications:- Corneal strengthening
Contraindications:- Corneal thickness, with epithelium, less than 325 µm- Pregnancy, nursing women, children- History of epithelial healing problems- Refractive keratotomy- Herpetic keratitis (UV can activate herpes)- Rheumatic disorders- Known sensitivity against one of the ingredients- Corneal melting
Other information:- ParaCel Part 1 & Part 2are sterile medical devices(CE 0482).
- 1 syringe of each solution for use for one eye only.
- Any remaining solution should be discarded.

Manufacturer:

0482

Medio-Haus Medizinprodukte GmbH
Brunswiker Straße 50, 24105 Kiel, Germany
Distributed by:
Avedro, Inc.
201 Jones Road, 5th Floor West., Waltham, MA, 02451 USA.

Storage:- Store in dark place- Storage temperature ≤ 28° C- Discard solution 12 hours after opening outer package- See expiry date
- Sterile if package is not broken, do not use if package is damaged- Do not remove from dark bag prior to use.
Side effects:(adverse effects without specifying the frequency)
Hypersensitivity reactions (burning) may occur temporarily. These
usually resolve after discontinuation.
Possible Risk:(without specifying the frequency)- Corneal edema- Stromal scarring- Inclusions- Corneal haze
- Keratitis by bacteria- Sterile infiltrates- Corneal calcification
Manufacturing LOTBest before

See directions for use

Single use only

Steam-sterilized

Storage not over 28°C

Manufacturer:

0482

Medio-Haus Medizinprodukte GmbH
Brunswiker Straße 50, 24105 Kiel, Germany 28°C

Distributed by:
Avedro, Inc. End-packed productStore in the darksterilized
withWest.,
Ethylene
oxide
201 Jones Road,
5th Floor
Waltham,MA, 02451 USA

ML-00024 Rev C