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New Device Approval

JSZ Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear - P040029

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Names: JSZ Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear
Manufacturer: Szabocsik and Associates
Address: 203 North Wabash Avenue, Suite 1200, Chicago, IL 60601
Approval Date: September 29, 2004
Approval Letter: http://www.fda.gov/cdrh/pdf4/p040029a.pdf

What is it? The JSZ Orthokeratology (oprifocon A) Contact Lenses are rigid, gas permeable contact lenses used for orthokeratology, a process that temporarily corrects nearsightedness (myopia). The patient wears these lenses overnight and removes them in the morning. During the day, nearsightedness is temporarily corrected or greatly reduced.

 How does it work? The JSZ Orthokeratology (oprifocon A) Contact Lenses apply slight pressure to the center of the cornea, causing it to temporarily flatten. The flattened cornea redirects light onto the back surface of the eye (the retina) at an angle that can compensate for nearsightedness. Since the cornea is elastic, it gradually regains its shape throughout the day causing nearsightedness to return. Usually, patients must wear the lenses every night to maintain corrected vision. When the lenses are removed each morning they must be cleaned and disinfected using a chemical disinfection system.

 When is it used? The JSZ Orthokeratology (oprifocon A) Contact Lenses may be used:

• for the temporary correction of nearsightedness,
• in patients with or without vision distortion (astigmatism),
• overnight as part of an orthokeratology fitting program.

 What will it accomplish? When worn overnight, these lenses temporarily correct or reduce nearsightedness. This may allow the user to stop wearing glasses or contact lenses during the day.

 When should it not be used? The lenses should not be worn by patients who have any of the following:

• inflammation or infection of the eye,
• disease or injury in or around the eye or eyelids,
• severe insufficiency of tears (dry eyes),
• any other medical condition that might interfere with contact lens wear,
• reduced corneal sensitivity,
• red or irritated eyes, or
• allergic reaction to contact lens solutions.

 Additional information:Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf4/p040029.html

Other:

National Institutes of Health (NIH) illustration of the eye:
http://www.nei.nih.gov/photo/eyean/index.asp

NIH information on contact lenses:
http://www.nlm.nih.gov/medlineplus/eyewear.html

NIH information on the prevention of infection and corneal ulcers:
http://medlineplus.nlm.nih.gov/medlineplus/ency/article/001032.htm#visualFile

FDA information on buying contact lenses online:
http://www.fda.gov/cdrh/consumer/buycontactqa.html

Updated October 5, 2004

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