Indications for use
The OMNI® Surgical System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example Healon or HealonGV* from Abbott Medical Optics (AMO), Amvisc* from Bausch & Lomb, or PROVISC* from Alcon, during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures.
Disclaimer
The OMNI® Surgical System is cleared (indicated) by FDA for the uses set forth above. While the OMNI® Surgical System is not specifically cleared for transluminal canal dilation, there is support for its use in transluminal canal dilation in the literature and medical textbooks, and ab interno trabeculotomy, for which it is FDA-cleared, is referred to as a MIGS procedure in the literature and medical textbooks and dictionaries. A current list of references/publications is available through Sight Sciences, Inc.
Warnings
1. Do not use in cases where there is insufficient visualization of the anterior chamber. 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 surgeon view.
2. Maintain direct microscopic 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.
3. 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 the appropriate management of intraocular pressure, including medication or surgery.
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 including toxic anterior segment syndrome (TASS), 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.
*Trademarks are property of their respective owners.