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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.
 
DeviceIC-8 Apthera Intraocular Lens (IOL)
Generic Nameextended depth of focus intraocular lens
Regulation Number886.3600
ApplicantAcuFocus, Inc.
32 discovery
suite 200
irvine, CA 92618
PMA NumberP210005
Date Received02/24/2021
Decision Date07/22/2022
Product Code POE 
Docket Number 22M-1672
Notice Date 07/27/2022
Advisory Committee Ophthalmic
Clinical TrialsNCT03633695
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the IC-8 Apthera IOL. The device is indicated for unilateral implantation for the visual correction of aphakia and to create monovision in patients of age 22 or older who have been diagnosed with bilateral operable cataract, who have up to 1.5 D of astigmatism in the implanted eye, and who do not have a history of retinal disease and who are not predisposed to experiencing retinal disease in the future. The device is intended for primary implantation in the capsular bag, in the non-dominant eye, after the fellow eye has already undergone successful implantation (uncorrected distance visual acuity 20/32 or better and best-corrected distance visual acuity 20/25 or better) of a monofocal or monofocal toric IOL that is targeted for emmetropia. The refractive target for the IC-8 Apthera IOL should be -0.75 D. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal or monofocal toric IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004  
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