CAUTION: Federal (USA) 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 use of this device is contraindicated if one or more of the following conditions exist:
The surgeon should be familiar with the directions 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.