IC-8 Apthera Intraocular Lens (IOL)

FDA Premarket Approval P210005

Pre-market Approval Supplement Details

DeviceIC-8 Apthera Intraocular Lens (IOL)
Generic NameExtended Depth Of Focus Intraocular Lens
ApplicantAcuFocus, Inc.32 Discoverysuite 200irvine, CA 92618 PMA NumberP210005 Date Received02/24/2021 Decision Date07/22/2022 Product Code POE  Advisory Committee Ophthalmic Clinical TrialsNCT03633695 Expedited Review Granted? No
Date Received2021-02-24
Decision Date2022-07-22
PMAP210005
SupplementS
Product CodePOE 
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination ProductNo
Applicant AddressAcuFocus, Inc.
32 Discovery
suite 200
irvine, CA 92618 PMA NumberP210005 Date Received02/24/2021 Decision Date07/22/2022 Product Code POE  Advisory Committee Ophthalmic Clinical TrialsNCT03633695
Expedited Review Granted? No Combination ProductNo Approval Order Statement  
The IC-8 Apthera IOL 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. Supplements:  

Supplemental Filings

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Supplement NumberDateSupplement Type
P210005Original Filing

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