Instructions For Use®
 ROSS H
MedioCRiboflavin Solution for Corneal Cross-Linking
For epithelium-off or epithelium-on procedures
Contents:-MedioCROSS H syringe (1) – Syringe filled with 1.5 ml (~100 drops) MedioCROSS H

Note to the Patient:

Note to the Doctor:-FOR SINGLE USE ONLYTO BE USED IN EPI-ON AND EPI-OFF PROCEDURESNO SIMULTANEOUS APPLICATION OF ANOTHER
THERAPEUTIC OPHTHALMIC MEDICATION-Composition (per 100 ml):
-Characteristics:

0.1% Riboflavin
Water for injection-Usage:
1.

2.

3.
4.
5.

6.
7.

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

Possible risks: (without specifying the frequency)-Progressive keratoconus
Iatrogenic ectasia
Pellucid marginal degeneration

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

Other information:-

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 eyemedicine

Manufacturer:

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

Side effects: (adverse effects without specifying the frequency)

Contraindications:-Riboflavin (vitamin B2) is a water-soluble yellow substance

Storage:

Check corneal thickness after instillation of MedioCROSS(D/M) by means of ultrasound pachymetry. If corneal
thickness is less than 400 µm corneal thickness must be
increased by means of MedioCROSS H (hypotonicriboflavin solution) to ensure endothelial safety.
Apply two drops MedioCROSS H every 5 to 10 seconds
until the corneal thickness increases to at least 400 µm.
This step may be faster if the eyelid speculum is removed
from the patient’s eye and the patient is allowed to close
his/her eye in between drop applications.
After reaching a corneal thickness of at least 400 µm
radiation treatment with a UV-radiation system can start.
Continue instilling 1 drop MedioCROSS (D/M) according toinstructions.
When radiation stops clean eye with (chilled) salinesolution. (UV time depends on UV system used &procedure detailed in system manual).
Insert bandage contact lens when using MedioCROSS D,MedioCROSS M.
Apply antibiotic ointment.

Indications:-AFTER APPLICATION THE VISUAL ACUITY IS
TEMPORARILY REDUCED.
DO NOT DRIVE, DO NOT USE ANY MACHINERY, AND
WAIT UNTIL THE NORMAL VISUAL ACUITY HAS BEEN
RESTORED.

-MedioCROSS H is a sterile medical device (CE 0482).
1 syringe of MedioCROSS H 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.

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.

Manufacturing LOTBest before

See directions for use

Single use only

Steam-sterilized
Endpacked productsterilized with Ethylene
Oxide25°C

Storage not over 25°C
Store in the dark

LBL-00334 Rev E