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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Namelens, intraocular, toric optics
Generic Name intraocular lens
Regulation Number886.3600
PMA NumberP980040
Supplement NumberS039
Date Received04/30/2012
Decision Date04/15/2013
Product Code
MJP[ Registered Establishments with MJP ]
Docket Number 13M-0463
Notice Date 04/24/2013
Advisory Committee Ophthalmic
Clinical Trials NCT01098812
Supplement Typepanel track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval of the tecnjs® toric 1-piece iol, models zct150, zct225, zct300 and zct400, and the tecnis® toric calculator system. This device is indicated for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire improved uncorrected distance vision, reduction in residual refractive cylinder and increased spectacle independence for distance vision. The device is intended to be placed in the capsular bag.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress