ClearView 3 IOL

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

SBL-3 Multifocal Intraocular Lens

Generic Name

Lens, multifocal intraocular

PMA Number

P200020 ↗

FDA Product Code

MFK

Device Class

Class III

Regulation

21 CFR Part 886.3600

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

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See all devices from Lenstec, Inc. →

• What is the primary purpose of the ClearView 3 IOL, and who is it designed for?

  The ClearView 3 IOL (SBL-3 Multifocal Intraocular Lens) is designed for primary implantation to correct aphakia in adult patients following cataract removal. It specifically targets patients with 1 diopter or less of pre-existing corneal astigmatism and aims to mitigate presbyopia by providing a bifocal optical design. This design improves near visual acuity while maintaining comparable distance and intermediate vision compared to aspheric monofocal alternatives.

• Is the ClearView 3 IOL intended for reuse, or is it meant for single-use only?

  The ClearView 3 IOL is explicitly supplied sterile and intended for single-use only. This aligns with standard sterile surgical protocols, ensuring patient safety and preventing cross-contamination in ophthalmic settings.

• How should the ClearView 3 IOL be stored, and what considerations should be taken into account?

  The ClearView 3 IOL must be stored and handled according to sterile surgical protocols due to its sterile packaging. Since it is not MRI-compatible, it should be stored in an environment where it won’t be exposed to MRI machines, as this could potentially damage or alter its properties. Always follow manufacturer guidelines for storage conditions to maintain sterility and functionality.

• What are the key differences in visual outcomes when using the ClearView 3 IOL compared to an aspheric monofocal IOL?

  The ClearView 3 IOL provides improved near visual acuity compared to aspheric monofocal IOLs while maintaining comparable distance and intermediate vision. Its bifocal design is intended to reduce the need for additional vision correction tools (like glasses or magnifying lenses) for near tasks, as evidenced by patient-reported outcomes.

• How do I identify the specific lot or serialized variant of the ClearView 3 IOL I am using?

  Each ClearView 3 IOL is available in multiple serialized variants, identifiable by registration numbers such as 3002807314, 1119421, or others listed in the product documentation. These numbers help track individual units for inventory and quality assurance purposes.