SBL-3 Multifocal Intraocular Lens

FDA Premarket Approval P200020

Pre-market Approval Supplement Details

DeviceSBL-3 Multifocal Intraocular Lens
Generic NameLens, Multifocal Intraocular
ApplicantLenstec, Inc.1765 Commerce Avenue Northst. Petersburg, FL 33716 PMA NumberP200020 Date Received03/16/2020 Decision Date07/22/2022 Product Code MFK  Advisory Committee Ophthalmic Clinical TrialsNCT02487160 Expedited Review Granted? No
Date Received2020-03-16
Decision Date2022-07-22
PMAP200020
SupplementS
Product CodeMFK 
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination ProductNo
Applicant AddressLenstec, Inc.
1765 Commerce Avenue North
st. Petersburg, FL 33716 PMA NumberP200020 Date Received03/16/2020 Decision Date07/22/2022 Product Code MFK  Advisory Committee Ophthalmic Clinical TrialsNCT02487160
Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval For The Lenstec SBL-3 Multifocal Intraocular Lens. This Lenstec SBL-3 Multifocal Intraocular Lens Is Indicated For Primary Implantation For The Visual Correction Of Aphakia, In Adult Patients With 1 Diopter Or Less Of Pre-existing Corneal Astigmatism, In Whom A Cataractous Lens Has Been Removed. The Lens Mitigates The Effects Of Presbyopia By Providing A Bifocal Correction. Compared To An Aspheric Monofocal IOL, The Lens Provides Improved Near Visual Acuity, While Maintaining Comparable Distance And Intermediate Visual Acuity. The Lens Promotes The Less Frequent Use Of Vision Correction Choices At Near Distance (including Glasses, Contact Lenses, Magnifying Glasses, And Digital Adjustments On Electronic Devices), Compared To An Aspheric Monofocal IOL, As Reported In Patient-reported Outcomes. The SBL-3 Multifocal IOL Is Intended For Capsular Bag Placement Only. Supplements:  

Supplemental Filings

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Supplement NumberDateSupplement Type
P200020Original Filing

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