Instructions For Use®
 ROSS TE
MedioCRiboflavin Solution for Corneal Cross-Linking
For trans-epithelium (epi-on) procedure
Contents:-MedioCROSS TE syringe (1) with dropping adapter (1) – Syringe filled with 2.0 ml (~40 drops) MedioCROSS TE

Note to the Doctor:-Note to the Patient:

FOR SINGLE USE ONLYTO BE USED ONLY IN EYES WITH INTACTEPITHELIUMNO SIMULTANEOUS APPLICATION OF ANOTHER
THERAPEUTIC OPHTHALMIC MEDICATION-Characteristics:

Composition (per 100 ml):
-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.

-0.25% RiboflavinHydroxypropylmethylcellulose (HPMC)
Benzalkoniumchloride
Sodium Chloride
Disodium hydrogenphosphate x 12H2O
Sodium dihydrogenphosphate x 2H2O
Water for injection

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

Storage:
Usage:For surface applications:
1. Do not remove corneal epithelium.
2. Ensure that the patient is in a supine position on a patient
table or chair.
3. Measure corneal thickness with ultrasound pachymeter. Ifcorneal thickness is less than 400 µm increase corneal
thickness by means of MedioCROSS H (hypotonicriboflavin solution) to ensure endothelial safety.
4. Apply sufficient MedioCROSS TE to completely cover thewhole cornea and repeat this procedure every 2 minutes forat least 20 minutes. Instruct the patient to keep his eyes
closed between applications.
5. Apply a topical anaesthetic to the cornea as needed.
6. Apply a lid speculum using standard clinical techniques.
7. Flush the cornea completely with BSS.
8. Initiate UV treatment (with e.g. CCL-Vario, CCL-365,XLink®, KERA-X, UV-X®).
9. Wet the cornea with BSS as needed.
10. Complete the procedure using standard clinical techniques.
Indications:-Progressive keratoconus
Iatrogenic ectasia
Pellucid marginal degeneration-Side effects: (adverse effects without specifying the frequency)
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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

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

Other information:

Corneal thickness, with epithelium, less than 400 µm
Epithelial healing problems
Refractive keratotomy (Intra PRK, LASIK Xtra)
Corneal melting
Pregnancy, nursing women, children
Herpetic keratitis (UV can activate herpes)
Rheumatic disorders
Known sensitivity against one of the ingredients
Simultaneous application of other or additional eye
medicine

Manufacturer:

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

Possible risks: (without specifying the frequency)Contraindications:-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 TE is a sterile medical device (CE 0482).
1 syringe of MedioCROSS TE 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 productsterilized with Ethylene
Oxide

Single use only
25°C

Storage not over 25°C
Store in the dark

LBL-00335 Rev D