| Device | SBL-3 Multifocal Intraocular Lens |
| Generic Name | Lens, Multifocal Intraocular |
| Applicant | Lenstec, 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 Received | 2020-03-16 |
| Decision Date | 2022-07-22 |
| PMA | P200020 |
| Supplement | S |
| Product Code | MFK |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Lenstec, 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: |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200020 | Original Filing | |
| S002 | 2022-10-20 | Normal 180 Day Track No User Fee |
| S001 | 2022-08-18 | Normal 180 Day Track No User Fee |