Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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

Trade Name

Bausch + Lomb ULTRA for Presbyopia

Bausch + Lomb ULTRA for Astigmatism

Bausch + Lomb ULTRA

Bausch + Lomb ULTRA Multifocal for Astigmatism

Device Name

Visibility Tinted Soft Corrective Contact Lenses, Daily Wear and Extended Wear (samfilcon A)

Model / Reference

Many

FDA applicant

Bausch & Lomb, Incorporated

Primary DI / UDI-DI

0196527M0006GN, 0196527M0007GQ, 0196527M0004GJ, 0196527M0005GL, 0196527M0008GS

Basic UDI-DI

0310119B0018ZA

510(k) Number

K182249 ↗

FDA Product Code

LPL

EMDN Code

Q0210040102 Contact lenses - hydrogel, reusable

Device Class

Class IIa EUDAMED

Class II 510(k)

Regulation

21 CFR Part 886.5925

Special Device Type

Standard soft contact lenses

EU market of registration

Netherlands

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

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• Are these contact lenses designed for continuous wear, or are they meant for daily wear only?

  The Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens is explicitly designed for daily wear only, as stated in the device description. This means they are intended to be worn during the day and removed before sleeping, rather than being worn continuously for extended periods.

• How are these lenses supplied, and are they sterile?

  These lenses are supplied as single-use, non-sterile disposable lenses. Since they are non-sterile, they must be handled and stored according to standard ophthalmic hygiene protocols before use, such as cleaning and disinfecting the lens case and hands.

• What materials are used in these lenses, and how does that affect comfort?

  The Ultra lenses are made from silicone hydrogel material (samfilcon A), which balances oxygen permeability with comfort for extended daily wear. This material is designed to allow sufficient oxygen transmission to the cornea while maintaining softness and moisture retention, reducing dryness and irritation.

• How do I determine the correct size or power for a patient, and are there multiple options available?

  The lenses come in multiple sizes and powers, as indicated by the listed FEI (Foreign Equipment Identifier) numbers in the specifications. These numbers correspond to different prescriptions and base curves, allowing for customization to fit a wide range of prescriptions for presbyopia and astigmatism. A clinician should select the appropriate FEI number based on the patient’s prescription and corneal measurements.

• What regulatory pathways were followed for this device, and how does that impact its use?

  The Ultra lenses were cleared through the FDA 510(k) pathway and comply with MDR (Medical Device Regulation) standards. This means they have undergone evaluation to demonstrate substantial equivalence to a predicate device, ensuring safety and performance for correcting presbyopia and astigmatism in daily-wear scenarios. The regulatory route confirms their suitability for ophthalmic use as intended.