INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR BAERVELDT® GLAUCOMA IMPLANTS
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 glaucomas, patients who have failed conventional surgery, congenital glaucomas and secondary glaucomas due to uveitis, epithelial downgrowth, etc.
Bacterial conjunctivitis, bacterial corneal ulcers, endophthalmitis, orbital cellulitis, bacteremia or septicemia, active scleritis and/or no light perception.
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). AMO single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. The reuse/resterilization/reprocessing of AMO single-use medical devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility. AMO single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user.
The complications during and after surgery include, but are not limited to: chorodial 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.
Reference the labeling for a complete listing of Indications and Important Safety Information.