Acuvue (Etafilcon A) Contact Lens, Clear with Visibility Tint and UV Blocker, Daily Wear

• • Terminated Z-1211-2018 FDA Class II ·initiated 19 Oct 2017

  Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.

• • Terminated Z-0734-2012 FDA Unclassified (pre-2012) ·initiated 1 Dec 2011

  Johnson & Johnson Vision Care, Inc. recalled their 1-DAY ACUVUE MOIST Brand Contact Lenses for ASTIGMATISM due to a lot being mixed. The secondary carton lot number and power are not the same as on the primary package inside the carton.

Full name

Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint with UV Blocker, for Daily Wear

510(k) Number

K051900 ↗

FDA Product Code

MVN

Device Class

Class II

Regulation

21 CFR Part 886.5925

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 reusable or designed for single-use only?

  These ACUVUE (etafilcon A) contact lenses are explicitly designed for single-use only. They must be discarded after each removal to maintain hygiene and safety, as outlined in the device description.

• What sizes or models are available for this contact lens?

  This product comes in multiple sizes and models, each corresponding to a unique FEI number (e.g., 3015533540, 3012546757, etc.). The exact specifications for each size are not detailed here, but the variety ensures compliance with regulatory standards for ophthalmic use and accommodates different prescription needs.

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

  The lenses are supplied in sterile packaging, ensuring they are ready for immediate use without additional sterilization. This is standard for single-use contact lenses to prevent contamination and maintain safety.

• What is the purpose of the visibility tint and UV blocker in these lenses?

  The visibility tint makes it easier for users to locate the lens when handling it, while the integrated UV blocker provides protection against ultraviolet radiation, reducing potential eye damage from prolonged sun exposure.

• What regulatory pathway was followed for this device’s approval?

  This device was cleared through the FDA 510(k) pathway (K051900) under a special classification within the Ophthalmic Advisory Committee (OP). The submission was deemed *substantially equivalent* to a predicate device, ensuring compliance with FDA regulations for contact lenses.