INDICATIONS FOR USE

The SION™ Surgical Instrument is a sterile, single use, manually operated device used in ophthalmic surgical procedures to excise trabecular meshwork.

CONTRAINDICATIONS

Do not use the SION™ if there is inadequate corneal clarity, or poor visualization of angle structures or in any situations where the anterior chamber angle has been damaged (i.e., from trauma or surgery) or it may not be possible to pass the device through Schlemm’s canal.

SION™ is contraindicated in patients: with angle recession, neovascular glaucoma, chronic angle closure, narrow angle glaucoma, narrow inlets with plateau iris, peripheral anterior synechiae, traumatic, malignant, or uveitic glaucoma; it is also contraindicated in patients who have had previous argon laser trabeculoplasty, ab interno devices implanted in or through Schlemm’s Canal, or prior incisional glaucoma surgery including trabeculotomy, goniotomy.

WARNINGS

Always maintain direct microscopic and gonioscopic visualization of the instrument tip during the procedure to avoid inadvertently damaging intraocular structures. Avoid touching the SION™ tip to any surfaces as this may damage it. Do not use the SION™ tip to create a corneal incision.

POTENTIAL ADVERSE EVENTS

Adverse events that may be reasonably associated with the use of the instrument include but are not limited to the following: anterior chamber shallowing, prolonged, or persistent intraocular inflammation, aqueous misdirection, choroidal effusion, suprachoroidal hemorrhage, Descemet’s membrane tear or detachment, corneal decompensation, corneal injury, corneal edema or opacification, intracorneal hematoma, cyclodialysis cleft, damage to posterior wall of Schlemm’s canal, hyphema, hypopyon, hypotony, hypotonic maculopathy, IOL dislocation, iris injury, tear, or iridodialysis, loss of vitreous, perforation of sclera, posterior capsular bag rupture, posterior capsule opacification, proliferative vitreoretinopathy, pupillary block, pupillary membrane formation, retinal detachment, retinal dialysis, retinal tears, vitreous hemorrhage, elevated IOP requiring treatment and endophthalmitis.

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