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RETISERT™ is approved by the FDA for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. IMPORTANT PRODUCT SAFETY INFORMATION As with any surgical procedure there is risk involved. Potential complications accompanying intraocular surgery to place RETISERT™ into the vitreous cavity may include, but are not limited to, the following: cataract formation, choroidal detachment, temporary decreased visual acuity, endophthalmitis, hypotony, increased intraocular pressure, exacerbation of intraocular inflammation, retinal detachment, vitreous hemorrhage, vitreous loss, and wound dehiscence. Based on clinical trials with RETISERT™, within 34 weeks post implantation approximately 60% of patients will require IOP lowering medications to control intraocular pressure. Within an average post-implantation period of approximately 2 years, approximately 32% of patients are expected to require filtering procedures to control intraocular pressure, and nearly all phakic eyes are expected to develop cataracts and require cataract surgery. The most frequently reported ocular adverse events in the overall study population were cataract, increased intraocular pressure, procedural complications, and eye pain. These events occurred in approximately 50% to 90% of patients. Procedural complication includes cataract fragments in the eye post-op, implant expulsion, injury, mechanical complication of implant, migration of implant, post-op complications, post-op wound complications, and wound dehiscence. RETISERT™ is a trademark of Bausch & Lomb Incorporated © Copyright 2006 Bausch & Lomb Incorporated
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