|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||AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS|
|Classification Name||lens, multifocal intraocular|
|Generic Name||intraocular lens|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to modify the current maximum level of ethylene ixide residual from "not to exceed 25 ppm" to "not to exceed 1. 0 ug/lens. ".