OMNI EDGE® Surgical System IMPORTANT PRODUCT INFORMATION
Indications for Use
The OMNI EDGE® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm’s canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.
Contraindications
Do not use the OMNI® in any situations where the iridocorneal angle is compromised or has been damaged (e.g., from trauma or surgery), since it may not be possible to visualize the angle or to properly pass the microcatheter.
Do not use the OMNI® in patients with angle recession; neovascular glaucoma; chronic angle closure; narrow-angle glaucoma; traumatic or malignant glaucoma; or narrow inlet canals with plateau iris.
Do not use the OMNI® Surgical System in quadrants with previous MIGS implants.
Please refer to the full Instructions for Use, available below, for warnings, precautions, and adverse event information.
Warnings
1. Do not use in cases where there is insufficient visibility to properly see the iridocorneal angle. The following conditions may prohibit sufficient visualization required for safe and successful cannula and microcatheter placement: corneal edema, corneal haze, corneal opacity, or any other conditions that may inhibit gonioscopic view of the iridocorneal angle and intended cannula entry location.
2. Perform gonioscopy prior to taking a patient to surgery to exclude congenital anomalies of the iridocorneal angle, anterior segment dysgeneses, peripheral anterior synechiae (PAS), rubeosis, and any other angle abnormalities that could lead to improper placement of the cannula and microcatheter and pose a hazard.
3. Maintain direct microscopic or gonioscopic visualization of the cannula tip and microcatheter tip at all times during the procedure to facilitate advancement and to avoid inadvertently damaging intraocular structures, kinking the microcatheter or unintended tearing of trabecular meshwork.
4. The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. If intraocular pressure is not adequately maintained after surgery, the surgeon should initiate appropriate management of intraocular pressure.
Potential adverse events
Adverse events that may be reasonably associated with the use of the OMNI® System in the eye include, but are not limited to, the following: anterior chamber shallowing, severe, prolonged, or persistent intraocular inflammation, endophthalmitis or other ocular infection, aqueous misdirection, Descemet’s membrane tear or detachment, intracorneal hematoma, choroidal effusion, suprachoroidal hemorrhage, corneal decompensation, corneal injury, corneal edema or opacification, unintended trabeculotomy, cyclodialysis cleft, hyphema, hypopyon, hypotony, hypotony maculopathy, IOL dislocation, cataract formation, iris injury, tear, or iridodialysis, loss of vitreous, perforation of sclera, posterior capsular bag rupture, proliferative vitreoretinopathy, pupillary block, pupillary membrane formation, retinal detachment, retinal dialysis, retinal flap tears, secondary surgical intervention, including, but not limited to, glaucoma surgery, and vitreous hemorrhage. Federal (USA) law restricts this device to sale, distribution, or use by or on the order of a physician.
