ACUVUE OASYS MAX 1-DAY Contact Lenses (senofilcon A)

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

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

• • Ongoing Z-2163-2025 FDA Class II ·initiated 12 Jun 2025

  Due to defects (bubbles/voids) identified during standard finished goods testing

Trade Name

ACUVUE OASYS MAX 1-Day Contact Lenses

ACUVUE OASYS MAX Contact Lenses

Model / Reference

Many

Primary DI / UDI-DI

733905G2EF, 733905G1ED, 733905K2ET

Basic UDI-DI

0733905a00011BK, 0733905a00013BP

510(k) Number

K210930 ↗

FDA Product Code

LPL

EMDN Code

Q021004010101, Q021004010102, Q0210040102

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

Ireland

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• ACUVUE OASYS MAX Contact Lenses

  Class IIa

  CE/MDR

• ACUVUE 2 Brand Contact Lenses

  Class IIa

  CE/MDR

• 1-DAY ACUVUE DEFINE Brand Contact Lenses with LACREON

  Class IIa

  CE/MDR

• Acuvue Oasys Multifocal

  Class IIa

  CE/MDR

• ACUVUE VITA Brand Contact Lenses for Astigmatism

  Class IIa

  CE/MDR

• ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS

  Class IIa

  CE/MDR

See all devices from Johnson & Johnson Vision Care, Inc. →

• Are these contact lenses designed for overnight wear, or are they strictly for daytime use only?

  These lenses are explicitly designed for daily wear only and are not intended for overnight use. The manufacturer specifies they are suitable for up to 16 hours per wear, which aligns with typical daytime use. Overnight wear is not supported or recommended.

• How are the ACUVUE OASYS MAX 1-Day lenses packaged and stored before use?

  The lenses are supplied as sterile, single-use units in individual, sealed packaging. Storage instructions require keeping them in their original packaging until use to maintain sterility and performance. This ensures they remain uncontaminated and ready for immediate wear.

• What is the regulatory pathway for these lenses, and how does it differ from other contact lens products?

  These lenses follow the FDA 510(k) clearance pathway, classified as Device Class II under the Ophthalmic specialty. The clearance states they are substantially equivalent to a predicate device, meaning their safety and effectiveness were compared to an already-approved product. This process ensures compliance with U.S. regulatory standards for soft contact lenses.

• Are these lenses reusable, or are they intended for single-use only?

  The lenses are strictly single-use only and must be discarded after removal. The design and labeling emphasize disposable use, meaning each lens is intended for one wear and should not be reused. This aligns with modern contact lens safety standards to prevent infection and maintain hygiene.

• What materials are used in these lenses, and how do they address common issues like dryness or blue light exposure?

  The lenses are made from senofilcon A, a proprietary material intended to reduce dryness and enhance visual clarity, particularly in environments with prolonged screen use or exposure to blue-violet light. This material is engineered to improve comfort and performance for users who spend extended periods on digital devices.