|Trade Name||BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES|
|Classification Name||lenses, soft contact, extended wear|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Revalidation of biofinity manufacturing line #4 with the following manufacturing changes: 1) an increase in temperature of the barrel heater on the injection molding machine; and 2) a consolidation change in the design of the fill and close module.