If your doctor has suggested RETISERT™ for the
treatment of chronic non-infectious uveitis
affecting the posterior segment of the eye, you
may have questions. This site is designed to help
you understand your condition, your treatment
with RETISERT™, as well as provide important safety
information associated with the product.
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
