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Important Safety Information – BAERVELDT® Glaucoma Implants

INDICATIONS

For use in patients (with prior vitrectomy for Pars Plana) with medically uncontrollable glaucoma and poor surgical prognosis, such as, but not limited to: neovascular glaucoma, aphakic/pseudophakic glaucoma, patients who have failed conventional surgery, congenital glaucoma and secondary glaucoma due to uveitis, epithelial downgrowth, etc.

WARNINGS

Do not use the device if sterile package integrity has been compromised. Do not resterilize the implant by any method. Do not reuse the implant. Do not store at temperatures above 45°C (113°F).

CONTRAINDICATIONS

Bacterial conjunctivitis, bacterial corneal ulcers, endophthalmitis, orbital cellulitis, bacteremia or septicemia, active scleritis and/or no light perception.

COMPLICATIONS/ADVERSE EVENTS

The complications during and after surgery include, but are not limited to: choroidal hemorrhage, hyphema, serous choroidal effusion, hypotony, flat anterior chamber, phthisis bulbi, retinal detachment, endophthalmitis, tube erosion, tube touch to cornea, tube block by iris or vitreous, bullous keratopathy, uveitis and diplopia.