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New Device Approval

Paragon CRT™ (paflufocon B), Paragon CRT ™100 (paflufocon D), Paragon Quadra RG ™(paflufocon B), and Paragon Quadra RG ™100 (paflufocon D) Rigid Gas Permeable Contact Lenses for Overnight Wear- P870024S043

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 Name: Paragon CRT™ (paflufocon B), Paragon CRT ™100 (paflufocon D), Paragon Quadra RG ™(paflufocon B), and Paragon Quadra RG ™100 (paflufocon D) Rigid Gas Permeable Contact Lenses for Overnight Wear
Manufacturer: Paragon Vision Sciences
Address: 947 East Impala, Mesa, AZ 85204-6619
Approval Date: June 13, 2002
Approval Letter: http://www.fda.gov/cdrh/pdf/P870024S043a.pdf

What is it? These are rigid gas permeable contact lenses used for corneal refractive therapy, a process that temporarily corrects nearsightedness (myopia). The patient wears the lenses overnight while sleeping and removes them upon wakening. During the day, nearsightedness is corrected or greatly reduced

How does it work? The Paragon CRT™ and Quadra RG ™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 is it used? The lenses are used for the temporary correction of nearsightedness. They can be used by patients with or without vision distortion (astigmatism). They are usually worn overnight as part of a corneal refractive therapy program. When the lenses are removed each morning, they must be cleaned using a chemical disinfection system.

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

When should it not be used? The lenses should not be worn by people 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

Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf/P870024S043.html

Other:

• NIH: Drawing of the eye:
  http://www.nei.nih.gov/photo/eyean/index.htm
• National Institutes of Health (NIH): Information on contact lens:
  http://www.nlm.nih.gov/medlineplus/eyewear.html
• NIH: Prevention of infection and corneal ulcers:
  http://medlineplus.nlm.nih.gov/medlineplus/ency/article/001032.htm#visualFile
• Food and Drug Administration: Buying contact lenses online:
  http://www.fda.gov/cdrh/consumer/buycontactqa.html

Updated 11/1/2002

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