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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.
 
DeviceClareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens
Generic Nameintraocular lens
ApplicantAlcon Laboratories, LLC
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP190018
Date Received07/11/2019
Decision Date01/07/2020
Product Codes HQL MJP 
Docket Number 20M-0108
Notice Date 01/10/2020
Advisory Committee Ophthalmic
Clinical TrialsNCT03170154
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the Clareon and Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (IOL).Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL):The Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) is indicated for primary implantation in the capsular bag in the posterior chamber of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (IOL):The Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lenses (IOLs) are indicated for primary implantation in the capsular bag in the posterior chamber of the eye for visual correction of aphakia and pre-existing corneal astigmatism to reduce residual refractive cylinder and improve uncorrected distance vision in adult patients in whom a cataractous lens has been removed. Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) with the AutonoMe Pre-loaded Delivery System:The Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) is indicated for primary implantation in the capsular bag in the posterior chamber of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) with the AutonoMe Pre-loaded Delivery System:The Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lenses (IOLs) are indicated for primary implantation in the capsular bag in the posterior chamber of the eye for visual correction of aphakia and pre-existing corneal astigmatism to reduce residual refractive cylinder and improve uncorrected distance vision in adult patients in whom a cataractous lens has been removed.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements: S006 S001 S002 S003 S004 S005 S010 S013 S014 S026 S038 S044 
 S008 S007 S021 S024 S025 S019 S020 S011 S009 S015 S016 
S017 S012 S023 S034 S035 S039 S040 S042 S043 S030 S031 S032 
S036 S037 S045 S046 S048 S049 S027 S028 S029 S047 
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