Lens, Multifocal Intraocular
Basic Information
- Device Name
- Lens, Multifocal Intraocular
- Trade Name
- SBL-3 Multifocal Intraocular Lens
- PMA Number
- P200020
- Device Class
- FDA Class 3
- Product Code
- MFK
- Generic Name
- Lens, multifocal intraocular
- Regulation Number
- 886.3600
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- July 22, 2022
- Date Received
- March 16, 2020
- Expedited Review
- N
- Docket Number
- 22M-1754
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MFK | Lens, Multifocal Intraocular | FDA class 3 | Ophthalmic |