B&L 58 Etafilcona Contact Lens

The B&L 58™ (Etafilcona) Contact Lens is specifically designed for extended wear, meaning it is intended to be worn continuously for prolonged periods—unlike daily-wear lenses, which are typically removed at night. Its key feature is continuous corneal reoxygenation, which helps maintain eye health while preserving optical clarity and comfort during extended use. This makes it suitable for patients who require or prefer lenses that can stay in place for longer durations without interruption.

The B&L 58™ lenses are supplied in sterile packaging for single-use only, meaning each lens is intended to be used once and then discarded. To preserve sterility, they must be handled according to the manufacturer’s instructions, which likely include keeping the packaging unopened until use and avoiding contamination. Since they are sterile at the point of sale, reuse is not recommended and could compromise safety or performance.

The B&L 58™ (Etafilcona) Contact Lens follows the FDA Premarket Approval (PMA) pathway, classified as a Class 3 device under regulation number 886.5925. This means the device underwent rigorous review by the FDA to ensure its safety and effectiveness for extended wear, as outlined in the approval number P850039. Clinicians or buyers can rely on this approval as evidence of the device’s compliance with stringent regulatory standards for extended-wear contact lenses.

While the provided data does not specify exact sizes or models in detail, the OpenFDA registration numbers and product code (LPM) indicate multiple FEI (Firm Establishment Identifier) numbers, suggesting the existence of various lot or batch-specific registrations for this device. These likely correspond to different base curves, diameters, or power prescriptions to accommodate different patient needs. For precise sizing options, refer to the manufacturer’s catalog or prescribing guidelines, as these details are not explicitly listed in the regulatory data.