|Trade Name||OPTI-SOAK(R) CONDITIONING SOLUTION ALCON WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID#84392|
|Classification Name||accessories, soft lens products|
|Generic Name||wetting, soaking, and disisfec. solut.|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a modification in the package insert to include addition of the following statement in the directions sections: "you may store your lenses in the unopened case until ready to wear, up to a maximum of thirty days. If your lenses are stored for longer periods of time, they must be cleaned and disinfected with fresh solution every thirty days and prior to wear. ".