Acuvue Oasys Bandage Contact Lenses 8.8

About the Product

Acuvue Oasys bandage contact lenses are senofilcon A silicone hydrogel soft contact lenses with a water content of 38 percent, a 14.0 mm diameter and a plano 0.00 power. They are supplied in two base curves, 8.4 mm and 8.8 mm.

These are bandage contact lenses, a lens category fitted and supplied by an eye care professional rather than bought for vision correction, which is why they come in a single plano power. They are worn on a two week replacement schedule, and they may be worn for up to seven days of continuous wear when an eye care professional directs it. Each lens carries a visibility tint to make it easier to see in the case.

Specifications

Regulatory

Class III device, prescription use only. Senofilcon A soft contact lenses are approved under premarket approval P040045. Supplement S001, approved 14 August 2007, added the therapeutic bandage lens indication and the trade name ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS. Product code LPM.

Approved Indications for Use, bandage lens indication as granted in P040045/S001:

Additionally indicated for therapeutic use as a bandage lens for the following acute and chronic conditions: 1) For corneal protection in lid and corneal abnormalities such as entropion, trichiasis, tarsal scars and recurrent corneal erosion. In addition it is indicated for protection where sutures or ocular structure malformation, degeneration or paralysis may result in the need to protect the cornea from exposure or repeated irritation. 2) For corneal pain relief in conditions such as bullous keratopathy, epithelial erosion and abrasion, filamentary keratitis, and post-keratoplasty. 3) For use as a barrier during the healing process of epithelial defects such as chronic epithelial defects, corneal ulcer, neurotrophic and neuroparalytic keratitis, and chemical burns. 4) For post surgical conditions where bandage lens use is indicated such as post refractive surgery, lamellar grafts, corneal flaps, and additional ocular surgical conditions. 5) For structural stability and protection in piggy back lens fitting where the cornea and associated surfaces are too irregular to allow for corneal rigid gas permeable (RGP) lenses to be fit. In addition the use of the lens can prevent irritation and abrasions in conditions where there are elevation differences in the host/graph junction or scar tissue. Lenses prescribed for therapeutic use may be worn for daily or extended wearing periods.