|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||CRYSTALENS SE, MODEL AT-45 SE|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the following modifications to the physician's labeling: change in the model number and trade name; change in directions for use to facilitate proper insertion and orientation of the lens; and, change in the existing recommendations for maximizing patient outcomes. The device, as modified, will be marketed under the trade name crystalens se (model at-45 se) and is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients with and without presbyopia. The crystalens se (model at-45 se) provides approximately one diopter of monocular accommodation which allows for near, intermediate, and distance vision without spectacles.