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 glaucomas; 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^oC (113^oF).

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.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

July 2002

Manufactured by:
AMO Groningen BV
9728 NX Groningen
The Netherlands
For AMO AB
S-112 87 Stockholm, Sweden

Distributed in the USA by:
Pfizer Inc.
235 East 42nd Street
New York, NY 10017

To learn more about Baerveldt® glaucoma implants, contact your AMO representative or call 1-800-366-6554 today (outside the USA, call +1-714-247-8200). The Future in Sight is a trademark and the AMO Logo and Baerveldt are registered trademarks of Advanced Medical Optics, Inc. Baerveldt is produced under at least one of the following U.S. Letters of Patents: 5,397,300; 5,558,629; 5,476,445; 5,178,604. Likewise patents pending and foreign equivalents available upon request. ©2004 Advanced Medical Optics, Inc., Santa Ana, CA 92705.