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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 NumberN16895
Supplement NumberS087
Date Received11/16/1999
Decision Date03/26/2001
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 1) the establishment of separate labeling for the therapeutic use indication; and, 2) combining the package insert and professional fitting guide into a single reference intended for the eye care practitioner. The device, as modified, will be marketed under the trade names soflens(r) (polymacon) contact lenses (plano t) and bausch & lomb optima(r) fw (polymacon) visibility tinted contact lenses. The lenses are indicated for use in the treatment and management of acute and chronic corneal pathologies such as bullous keratopathy, corneal ulcers and erosion, dry eyes, keratitis protection of cornea during and after surgery, accidental or surgical trauma, and entropion. When prescribed for therapeutic use, the soflens(r) (polymacon) contact lenses (plano t and optima(r) fw) may be worn for daily or extended wearing periods. The eye care practitioner should recommend either single-use disposable wear or a schedule of periodic replacement, and should provide instructions for cleaning, disinfection, and replacement of the lenses. The lenses may be disinfected using a chemical disinfection system. The lens should be inserted and removed only as the eye care practitioner has instructed.