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BAERVELDT® Glaucoma Implants

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REFERENCES

  1. Gedde S, Schiffman J, Feuer W, et al. Treatment outcomes in the tube versus trabeculectomy study after one year of follow-up. Am J Ophthalmol. 2007;143(1):9-22.
  2. Lloyd MA, Baerveldt G, Fellenbaum PS, et al. Intermediate-term results of a randomized clinical trial of the 350 - versus the 500 mm2 Baerveldt Implant. Ophthalmology. 1994;101(8):1456-1464.
  3. Gedde, S. et al. Treatment outcomes in the tube versus trabeculectomy (TVT) study after five years of follow-up. Am J Ophthalmol. 2012;153(5).
  4. Heuer DK, Lloyd MA, Abrams DA, et al. Which is better? One or two? A randomized clinical trial of single-plate versus double-plate Molteno implantation for glaucomas in aphakia and pseudophakia. Ophthalmology. 1992;99(10):1512-1519.
  5. Fellenbaum PS, Sidoti P, Heuer DK, Minckler DS, Baerveldt G, Lee PP. Experience with the Baerveldt implant in young patients with complicated glaucomas. J Glaucoma. 1995;4(2):91-97.
  6. Hodkin MJ, Goldblatt WS, Burgoyne CF, Ball SF, Insler MS. Early clinical experience with the Baerveldt implant in complicated glaucomas. Am J Ophthalmol. 1995(1);120:32.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR BAERVELDT® GLAUCOMA IMPLANTS

Rx Only

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, patients who have failed conventional surgery, congenital glaucomas and secondary glaucomas due to uveitis, epithelial downgrowth, etc.

CONTRAINDICATIONS

Bacterial conjunctivitis, bacterial corneal ulcers, endophthalmitis, orbital cellulitis, bacteremia or septicemia, active scleritis and/or no light perception.

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°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.

COMPLICATIONS/ADVERSE EVENTS

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.

ATTENTION

Reference the labeling for a complete listing of Indications and Important Safety Information.

PP2018MLT4018