DEC 2013

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

Issue link: https://digital.eyeworld.org/i/227001

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Page 7 of 74

THE 1960s CALLED. THEY WANT THEIR FILTRATION SURGERY BACK. It's time for a change. Discover Lumenal Control. The EX-PRESS® Glaucoma Filtration Device eliminates one of the most critical surgical variables. By standardizing the lumenal structure through which aqueous humor flows, you get consistent, predictable filtration. © 2013 Novartis 7/13 EXP13042JADC MyAlcon.com CAUTION: Federal law restricts this device to sale by or on the order of a physician. INDICATION: The EX-PRESS® Glaucoma Filtration Device is intended to reduce intraocular pressure in glaucoma patients where medical and conventional surgical treatments have failed. GUIDANCE REGARDING THE SELECTION OF THE APPROPRIATE VERSION: Prior clinical studies were not designed to compare between the various versions of the EX-PRESS® Glaucoma Filtration Device. The selection of the appropriate version is according to the doctor's discretion. CONTRAINDICATIONS: The use of this device is contraindicated if one or more of the following conditions exist: • Presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis. • Pre-existing ocular or systemic pathology that, in the opinion of the surgeon, is likely to cause postoperative complications following implantation of the device. • Patients diagnosed with angle closure glaucoma. WARNINGS/PRECAUTIONS: • The surgeon should be familiar with the instructions for use. • The integrity of the package should be examined prior to use and the device should not be used if the package is damaged and sterility is compromised. • This device is for single use only. • MRI of the head is permitted, however not recommended, in the first two weeks post implantation. ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings, precautions, complications and adverse events.

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