Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically)

• • Terminated Z-2916-2018 FDA Class II ·initiated 23 Jul 2018

  Johnson and Johnson Vision Care received a number of reports of a partially formed contact lens, which appears to the customer or consumer as visibly smaller in diameter, thicker/stiffer to the touch and more darkly tinted blue than the normal contact lens.

• 2 recalls, same reason

  • Terminated Z-1335-2013 FDA Class II ·initiated 21 Dec 2012
  • Terminated Z-1336-2013 FDA Class II ·initiated 21 Dec 2012

  Limited number of individual contact lens packages may not have been completely sealed.

510(k) Number

K062614 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

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  Class IIa

  CE/MDR

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  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 are they meant for single-use only?

  These lenses are explicitly designed for single-use only. The product description and FDA classification (Daily Wear) confirm they are not intended for reuse, even after cleaning or disinfection. Each lens is meant to be discarded after one wear to maintain safety and hygiene.

• Do these tinted lenses provide any functional benefit beyond aesthetics, or are they purely cosmetic?

  The tinted variants are intended for visibility enhancement or cosmetic purposes, as stated in the description. While they may improve contrast or reduce glare for some users, their primary purpose is not clinical correction but rather aesthetic or functional visibility improvement. The clear variant remains the standard for vision correction.

• Can these lenses be safely used during an MRI scan, or do they pose any risks?

  These lenses are not MRI-safe, meaning they should not be used during an MRI scan. The manufacturer explicitly notes this in the specifications, as metallic or conductive materials in lenses could pose risks in a magnetic field environment.

• How should these lenses be stored to ensure they remain effective and sterile?

  The lenses are non-sterile as supplied and must be handled and stored according to the manufacturer’s guidelines to maintain integrity. Since they are single-use, proper storage involves keeping them in a clean, dry environment away from direct sunlight or extreme temperatures until use. After opening, they should be used immediately and discarded.

• Are there multiple sizes or models available, or is this a one-size-fits-all product?

  These lenses come in multiple FEI (Fitting Equation Index) numbers, indicating a range of sizes and prescriptions to accommodate different corneal curvatures and refractive errors. The list of FEI numbers (e.g., 3015533540, 3012546757) confirms they are not a one-size-fits-all solution but rather tailored for professional fitting by eye care practitioners.