|Trade Name||ISERT GEMETRIC MODEL 750 AND ISERT GEMETRIC MODEL 751 INTRAOCULAR LENS (IOL)|
|Classification Name||intraocular lens|
|Applicant||HOYA SURGICAL OPTICS, INC.|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - specifications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for an optical design curvature modification to the isert® model 251 to add a controlled positive spherical aberration to the optic. The device, as modified, will be marketed under the trade name isert® gemetric model 751 and is indicated for implantation after extracapsular cataract extraction or phacoemulsification of cataracts in adults. This lens is intended for placement in the capsular bag.