Important Safety Information

CAUTION
Sale of this device is restricted to sale on the order of a physician.

INDICATIONS FOR USE:
The Hydrus Microstent is indicated for the reduction of intraocular pressure (IOP) in adult patients with primary open-angle glaucoma (POAG) as a standalone treatment or in conjunction with cataract surgery.

CONTRAINDICATIONS:
The Hydrus Microstent is contraindicated under the following circumstances or conditions: (1) In eyes with angle closure glaucoma; (2) In eyes with secondary glaucoma such as neovascular, uveitic, traumatic, or steroid-induced glaucoma, and glaucoma associated with increased episcleral venous pressure (EVP) e.g., Sturge-Weber Syndrome; (3) patients with known nickel allergy.

WARNINGS
Clear media for adequate visualization is required. Conditions such as corneal haze, corneal opacity or other conditions may inhibit gonioscopic view of the intended implant location. Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, peripheral anterior synechiae (PAS), angle closure, rubeosis and any other angle abnormalities that could lead to improper placement of the stent and pose a hazard.

PRECAUTIONS
The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. The safety and effectiveness of the Hydrus Microstent has not been established as an alternative to the primary treatment of glaucoma with medications, in patients 21 years or younger, eyes with significant prior trauma, eyes with abnormal anterior segment, eyes with chronic inflammation, eyes with glaucoma associated with vascular disorders, eyes with uveitic glaucoma, eyes with other secondary open angle glaucoma, or eyes that have undergone argon laser trabeculoplasty (ALT). The safety and effectiveness of use of more than a single Hydrus Microstent or with other metallic implants has not been established.

ADVERSE EVENTS
The most common intra-operative and post-operative device-related ocular adverse events reported include transient hyphema; peripheral anterior synechiae without device obstruction; partial or complete device obstruction; non-persistent anterior uveitis/iritis; subconjunctival hemorrhage; and device malposition.

MRI INFORMATION
The Hydrus Microstent is MR-Conditional meaning that the device is safe for use in a specified MR environment under specified condition. Please see the Instructions for Use and Patient Information Card for details.

Please refer to the Instructions for Use for complete product information.

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