2001 Addition Technology, Inc. acquired KeraVision assets.
KeraVision, Inc. was the former manufacturer of Intacs® Corneal Implants.
Intacs® Corneal Implants were originally developed for the correction of myopia.
2003 CE Mark granted for treatment of keratoconus.
2004 Received Humanitarian Device Exemption (HDE) from the FDA for keratoconus indication.
2007 Intacs® SK Corneal Implants added to CE Mark for treatment of severe keratoconus.
2013 AJL Ophthalmic, S.A. acquired Addition Technology, Inc., which is still the manufacturer.
Intacs® Corneal Implants are an ophthalmic medical device designed for the reduction or elimination of myopia and astigmatism in patients with keratoconus so that their functional vision may be restored and the need for a corneal transplant procedure can potentially be deferred. Intacs is the trademark name for micro-thin prescription inserts which were previously used as a form of refractive surgery in the treatment of low levels of myopia or nearsightedness, but has recently received FDA approval for keratoconus.
FDA Approval Intacs were approved under a Humanitarian Device Exemption (HDE) by the FDA in July 2004, allowing Intacs to be used for treating keratoconus. As part of the HDE approval, Addition Technology, the manufacturer of Intacs, has implemented an extensive training program in which each surgeon will be required to participate.
Intacs® Corneal Implants
Intacs® Corneal Implants and Intacs® SK Corneal Implants are an ophthalmic medical device designed for the reduction or elimination of myopia and astigmatism in patients with keratoconus so that their functional vision may be restored and the need for a corneal transplant procedure can potentially be deferred. When placed in the corneal stroma, outside of the patient’s central optical zone, the product reduces the cone by flattening the cornea.
Intacs® segments are designed to be placed in the periphery of the cornea, at approximately two-thirds depth, and are surgically inserted through a small radial incision in the corneal stroma. The Intacs® are designed to allow removal or replacement.Intacs® and Intacs® SK Corneal Implants are manufactured from polymethylmethacrylate (PMMA) and are available in different thicknesses, ranging from 0.210 mm to 0,500 mm. The product is designed with a fixed outer diameter and width. Intacs® and Intacs® SK Corneal Implants have positioning holes located at each end of the segment to aid in surgical manipulation.
The Intacs® SK segments are designed with rounded edges to potentially reduce the incidence of visual symptoms since de SK segments are placed closer to the patient’s central optical zone than the standard Intacs segments.
Intacs Surgery Procedure
This procedure involves placing the plastic inserts just beneath the surface of the eye in the periphery of the cornea. The procedure itself takes approximately 15 to 20 minutes usually in the doctor’s office. Topical anesthetic drops are used to numb the eye, and a clamp is used to hold the eye open throughout the procedure to prevent blinking
As with any surgical procedure, there are some risks, including infection. Some patients experience visual symptoms including difficulty with night vision, glare, halos, blurry and fluctuating vision.
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