|Trade Name||OPTI-FREE RINSING,DISINFECTING & STORAGE SOLUTION|
|Classification Name||accessories, soft lens products|
|Generic Name||all-purpose eye solution|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval of a multi-purpose solution for cleaning, rinsing, disinfecting, and storing soft (hydrophilic) contact lenses. This device is a modification of the approved opti-free rinsing, disinfecting, and storage solution due to the addition of low concentrations of surfactants. The solution will be marketed in 1. 5fl. Oz, 4fl. Oz. , 8fl. Oz. , 12fl. Oz. , & 16fl. Oz. Size bottles.