Instructions For Use®
 ROSS D
MedioCRiboflavin Solution for Corneal Cross-Linking
For epithelium-off procedure
Contents:
MedioCROSS D syringe (1) with dropping adapter (1) – Syringe filled with 3.0ml (~60 drops) MedioCROSS D
Note to the Doctor:-Note to the Patient:

FOR SINGLE USE ONLYNO SIMULTANEOUS APPLICATION OF ANOTHER
THERAPEUTIC OPHTHALMIC MEDICATION-Composition (per 100 ml):
-0.1% Riboflavin
DextranSodium Chloride
Disodium hydrogenphosphate x 12 H2O
Sodium dihydrogenphosphate x 2 H2OWater for injection

AFTER APPLICATION THE VISUAL ACUITY ISTEMPORARILY REDUCED.
DO NOT DRIVE, DO NOT USE ANY MACHINERY, AND
WAIT UNTIL THE NORMAL VISUAL ACUITY HAS BEEN
RESTORED.

Characteristics:-Riboflavin (vitamin B2) is a water-soluble yellow substance.
Dextran is a high polymer that can be used for adjustingviscosity of the solution.

Usage:Storage:

1.

After complete removal of the corneal epithelium, instil one
drop of MedioCROSS D onto the cornea at two minuteintervals for 20 minutes (= 10 drops).

2.

Check whether the anterior chamber is slightly yellow tomake sure that MedioCROSS D has completely penetrated
the cornea.

-3.

Check corneal thickness by means of ultrasoundpachymetry. If corneal thickness is less than 400 µm,corneal thickness must be increased by means ofMedioCROSS H (hypotonic riboflavin solution) to ensure
endothelial safety.

4.

After reaching a corneal thickness of at least 400 µm,
radiation treatment with a UV-radiation system can start.

5.

Continue instilling 1 drop of MedioCROSS D every two
minutes.

6.

When radiation stops clean eye with (chilled) salinesolution.

7.

Insert bandage contact lens.

8.

Apply antibiotic ointment.

-Side effects:(adverse effects without specifying the frequency)--

Progressive keratoconus
Iatrogenic ectasia
Pellucid marginal degeneration

Epithelial healing problems
Corneal melting
Pregnancy
Herpetic keratitis (UV can activate herpes)
Rheumatic disorders
Known sensitivity against one of the ingredients
Simultaneous application of other or additional eye
medicine

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 USACorneal staining
Keratitis by bacteria
Sterile infiltrates
Corneal opacity
Corneal oedema
Stromal scarring
Inclusions

Other information:

Contraindications:-Hypersensitivity reactions (burning) may occur
temporarily. These usually resolve after discontinuation.

Possible Risks (without specifying the frequency)

Indications:-Store in dark place
Storage temperature ≤ 25° C
Discard solution 12 hours after opening outer package
See expiry date
Sterile if package is not broken, do not use if package isdamaged
Do not remove from foil pouch prior to use.

-MedioCROSS D is a sterile medical device (CE 0482).

-1 syringe of MedioCROSS D is for use for one eye only.
Any remaining solution should be discarded.

-Use as directed. Medio-Haus Medizinprodukte GmbHcannot guarantee the warranted characteristics such asfunction, material properties or sterility if product is used ina manner that is not consistent with Usage describedabove, or if the product is reused.

Manufacturing LOTBest before

See directions for use
Steam-sterilized
Endpacked product sterilizedwith Ethylene Oxide

Single use only25°C

Storage not over 25°C
Store in the darkLBL-00332 Rev D