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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
Bausch & Lomb, Inc.
1400 north goodman st.
rochester, NY 14609-3547
PMA NumberP980006
Supplement NumberS007
Date Received03/03/2005
Decision Date05/27/2005
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding a therapeutic indication for the purevision contact lens. The device, as modified, will be marketed under the trade name bausch & lomb purevision (balafilcon a) visibility tinted contact lens for therapeutic use and is indicated for therapeutic use as a bandage contact lens for corneal protection and corneal pain relief during treatment of ocular pathologies as well as post-surgical conditions. Applications of the purevision contact lens include but are not limited to conditions such as the following: 1) for corneal protection in conditions such as entropion, trichiasis, tarsal scars, recurrent corneal erosion and post surgical ptosis for corneal protection; 2) for corneal pain relief in conditions such as bullous keratopathy, epithelial erosion and abrasion, filamentary keratitis, post-keratoplasty; 3) for use as a bandage during the healing process of conditions such as chronic epithelial defects, corneal ulcer, neurotrophic keratitis, neuroparalytic keratitis, chemical burns, and post surgical epithelial defects; and 4) for post surgical conditions that include bandage use such as lasik, prk, pk, ptk, lamellar grafts, corneal flaps, and additional corneal surgical conditions. Pure vision contact lenses for therapeutic use can also provide correction during healing if required.