Premarket Approval (PMA)

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.

• Trade Name: SOFLENS (POLYMACON) CONTACT LENSES
• Classification Name: lenses, soft contact, extended wear
• Generic Name: soft contact lens
• Regulation Number: 886.5925
• Applicant: BAUSCH & LOMB, INC.
• PMA Number: N16895
• Supplement Number: S084
• Date Received: 10/01/1996
• Decision Date: 01/30/1997
• Product Code: LPM [ Registered Establishments with LPM ]
• Advisory Committee: Ophthalmic
• Supplement Type: normal 180 day track
• Supplement Reason: labeling change - instructions
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for labeling modifictions to soflens(r) (polymacon) contact lenses including the following lens types (series): 03, 04, occasions(tm) multifocal, optima(tm) 38, optima(tm) 38/sp, u3, u4, sofspin(tm), h03, h04, b3, b4, p. A. 1, f3, h3, h4, n, naturaltine, optima(tm) fw, and seequence(tm). Modifications include: 1)removing the replacement system descriptors from labeling specific to the optima(tm) fw contact lenses; 2)adding monovisio fitting technique for all bausch & lomb soflens(r) (polymacon) contact lenses in this supplement;3)consolidating info in six fitting guides into 3 fitting guides for soflens(r), naturaltint(r), occasions(tm) multifocal, and p. A. 1 contact lenses; 4)consolidating 2 patient info booklets (1 for frequent replacement use and 1 for disposable use) for seequence(tm) (polymacon) visibility tinted contact lenses into a single patient info booklet (this modification results in deletion of the disposable wear indication); 5)formatting changes to package inserts, fitting fuides & patient info booklets to bring labeling up-to-date with recommendations in cdrh's current labeling guidance; and 6)separating the therapeutic indiation from the cosmetic labeling included in this supplement.