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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.
 
DeviceSBL-3 Multifocal Intraocular Lens
Generic Namelens, multifocal intraocular
Regulation Number886.3600
ApplicantLenstec, Inc.
1765 commerce avenue north
st. petersburg, FL 33716
PMA NumberP200020
Date Received03/16/2020
Decision Date07/22/2022
Product Code MFK 
Docket Number 22M-1754
Notice Date 08/02/2022
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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 
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