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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.
 
Trade NameCRYSTALENS TORIC ACCOMODATING POSTERIOR CHAMBER INTRAOCULAR LENS
Classification Namelens, intraocular, toric optics
Regulation Number886.3600
ApplicantBAUSCH & LOMB, INC.
PMA NumberP030002
Supplement NumberS027
Date Received05/08/2012
Decision Date05/20/2013
Product Code
MJP[ Registered Establishments with MJP ]
Docket Number 13M-0724
Notice Date 06/18/2013
Advisory Committee Ophthalmic
Clinical Trials NCT01140477
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the trulign toric posterior chamber intraocular lens (models: at50t, bl1at and bl1ut) and trulign toric calculator. This device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia and postoperative refractive astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia who desire reduction of residual refractive cylinder with increased spectacle independence and improved uncorrected near, intermediate and distance vision.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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