Preserflo Important Safety Information

INDICATIONS FOR USE

The MicroShunt is intended for reduction of intraocular pressure in eyes of patients with primary open angle glaucoma where IOP remains uncontrollable while on maximum tolerated medical therapy and/or where glaucoma progression warrants surgery.

CONTRAINDICATIONS

The implantation of the MicroShunt is contraindicated under the following circumstances and conditions: ANGLE CLOSURE GLAUCOMA; PRESENCE OF CONJUNCTIVAL SCARRING, PREVIOUS INCISIONAL OPHTHALMIC SURGERY INVOLVING THE CONJUNCTIVA OR OTHER CONJUNCTIVAL PATHOLOGIES (E.G., THIN CONJUNCTIVA, PTERYGIUM) IN THE TARGET QUADRANT; ACTIVE IRIS NEOVASCULARIZATION; ACTIVE INFLAMMATION (E.G., BLEPHARITIS, CONJUNCTIVITIS, SCLERITIS, KERATITIS, UVEITIS); SECONDARY GLAUCOMA SUCH AS POSTTRAUMATIC, PSEUDOEXFOLIATION OR PIGMENTARY; VITREOUS IN THE ANTERIOR CHAMBER; PRESENCE OF AN ANTERIOR CHAMBER INTRAOCULAR LENS (ACIOL); INTRAOCULAR SILICONE OIL.

WARNINGS

Rx only: This device is restricted to sale by, or on the order of, a physician. For one-time use only. Do not reuse or re-sterilise. Reuse, or re-sterilisation may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in serious patient injury, illness, blindness or death. Reuse, or re-sterilisation may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness, blindness, or death of the patient. After use, dispose of product and packaging in accordance with hospital, administrative, and/or local government policy. Long term effects of Mitomycin C (MMC) with the use of this device have not been evaluated. Necessary precautions and interventions on the use of MMC are highly recommended. The patient’s IOP should be monitored postoperatively. If IOP is not adequately maintained after surgery, appropriate additional therapy to maintain IOP should be considered. The MicroShunt should not be subjected to direct contact with petrolatum-based (i.e., petroleum jelly) materials (e.g., ointments, dispersions, etc.). No cutting or modification of the MicroShunt is allowed.

POTENTIAL COMPLICATIONS / ADVERSE EVENTS

The complications during and after surgery may include: Glaucoma progression not controlled, increase in cup-to-disc ratio (C/D), anaesthesia related complications, difficulty in inserting the MicroShunt, failure to implant the device, device malfunction, device repositioning, extended surgical procedure, tube migration out of anterior chamber, flat anterior chamber, shallow anterior chamber, excessive bleeding in anterior chamber or incision site or eye, MicroShunt touches cornea or iris, intraocular pressure too high or low, strabismus, viscoelastic used in anterior chamber, choroidal effusion or hemorrhage, retinal complications (retinal detachment, proliferative retinopathy), hyphema, hypotony or hypotony maculopathy, phthisis bulbi, endophthalmitis, tube erosion through conjunctiva, tube obstruction partial or complete (block by iris or vitreous or fibrin or debris), uveitis, iritis, diplopia, aqueous misdirection, corneal complications (abrasion, edema, ulceration, infection, decompensation, bullous keratopathy, endothelial cell loss, Descemet striae, keratitis), partial or complete vision loss, blurry vision, bleb leak, blebitis, cystic bleb, bleb failure, pupillary block, ptosis, macular edema, prolonged inflammation, use of glaucoma medications, ocular pain, conjunctival complications (buttonhole, dehiscence, dissection, hemorrhage, hyperemia, scar, tear, ulcer), iris adhesions/synechiae, iris abrasion, cataract development or progression, posterior capsule opacity, explantation of the MicroShunt, encapsulation reaction, foreign body sensation, fibrin in anterior chamber, visual field damage, unplanned glaucoma-related surgical re-intervention, optic disc hemorrhage, globe perforation, headache, vitreous hemorrhage, wound leak, and suture related complications.