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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceenVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL)
Generic NameLens, multifocal intraocular
ApplicantBausch & Lomb, Inc.
1400 N. Goodman St.
Rochester, NY 14609
PMA NumberP240005
Date Received03/08/2024
Decision Date10/10/2024
Product Codes MFK MJP 
Advisory Committee Ophthalmic
Clinical TrialsNCT03603600
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the enVista Envy™ hydrophobic acrylic intraocular lens (IOL) and the enVista Envy™ toric hydrophobic acrylic IOL. The enVista Envy hydrophobic acrylic IOL (non-preloaded model: EN / preloaded into shuttle model: EPN) is indicated for primary implantation in the capsular bag of the eye in adult patients for the visual correction of aphakia with less than or equal to 1.0 D preoperative corneal astigmatism following removal of a cataractous lens to mitigate the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity to an aspheric monofocal IOL. The enVista Envy Toric hydrophobic acrylic IOL (non-preloaded model: ETN / preloaded into shuttle model: ETPN) is indicated for primary implantation in the capsular bag of the eye in adult patients for the visual correction of aphakia and corneal astigmatism following removal of a cataractous lens to mitigate the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity to an aspheric monofocal IOL.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S003 S002 S001 S004 
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