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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceenVista One-Piece Hydrophobic Acrylic Toric Intraocular Lens (Model MX60T)
Generic NameLENS, INTRAOCULAR, TORIC OPTICS
Regulation Number886.3600
ApplicantBausch & Lomb, Inc.
50 Technology Drive
Irvine, CA 92618
PMA NumberP910056
Supplement NumberS027
Date Received10/30/2017
Decision Date06/08/2018
Product Code MJP 
Docket Number 18M-2237
Notice Date 06/19/2018
Advisory Committee Ophthalmic
Clinical TrialsNCT01852084
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the enVista One-Piece Hydrophobic Acrylic Toric Intraocular Lens (Model MX60T). The device is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens for improved uncorrected distance vision.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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