The Molteno3® has has a CE Mark (Conformité Européenne) and US Food and Drug Administration (FDA) 510(k) #KK062252.
INDICATIONS: The Molteno3® Glaucoma Drainage Device is indicated to reduce intraocular pressure in neovascular glaucoma and glaucoma where medical and conventional surgical treatments have not been successful, to control the progression of disease.
CONTRAINDICATIONS: Patients with the following conditions may not be suitable candidates for the Molteno3® Glaucoma Drainage Device: 1. intraocular infection, 2. rheumatoid arthritis, scleritis and immune corneal melt syndromes, 3. Scleral Buckle.
COMPLICATIONS: Possible complications with the use of the Molteno3® Glaucoma Drainage Device include, but are not limited to: choroidal detachment, retinal detachment, expulsive haemorrhage, pupillary block, lenticulo-ciliary block, shallowing and flattening of the anterior chamber, intraocular infection, diplopia, loss of central vision, hypotony and corneal endothelial damage.
ADVERSE EVENTS: Possible adverse events with the use of the Molteno3® Glaucoma Drainage Device include, but are not limited to: corneal endothelial damage when the tube touches the corneal endothelium, breakdown of the tissues overlying the bleb, diplopia when the placement of the implant interferes with the action of the extraocular muscles, corneal decompensation, progression of lens opacities, cystoid macular oedema, retinal detachment and intraocular infection.
