Lenses, Soft Contact, Daily Wear

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2025-10-24Open, ClassifiedProcess control

  Alcon PRECISION1 One-Day Contact Lenses, -2.25D.

  Potential for a weak seal in some units resulting in compromise in sterility.

• 2025-07-23Open, ClassifiedNonconforming Material/Component

  ACUVUE OASYS MAX 1-Day MULTIFOCAL

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

• 2024-09-30Open, ClassifiedProcess change control

  DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,

  Material with a quality issue was used in contact lens production, so contact lenses may not meet quality and/or performance standards for the entirety of their labeled shelf life, and wearing these lenses may lead to temporary issues such as irritation, redness, or blurred vision.

• 2023-03-23Open, ClassifiedProcess control

  Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90

  The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.

• 2023-01-24Open, ClassifiedProcess control

  MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.

  Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.

• 2019-04-11TerminatedEquipment maintenance

  ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack.

  One lot of ACUVUE OASYS for ASTIGMATISM Brand Contact lenses has the potential for a limited number of individual contact lens packages to have an incomplete packaging seal.

• 2015-11-04TerminatedProcess control

  BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lenses are available in 5 pack, 30 pack and 90 pack sizes; Biotrue ONEday Foil - Part Number 8098001, Biotrue ONEday 5 pack Carton International - Part Number 8101403, and Biotrue ONEday 90 pack Carton International - Part Number 8098203.

  The firm determined that 25 lots had been manufactured with a minor surface defect occurring in the optical surface on each lens. Complaints of Halo or Poor Visual Acuity.

• 2014-10-24TerminatedOther

  ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling.

  Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification.

• 2013-05-17TerminatedPackaging

  1-DAY ACUVUE MOIST Brand Contact Lenses, soft disposable contact lenses. The Vistakon (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically), with UV Blocker for Daily Disposable Wear (spherical) is indicated for daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with not diseased eyes who may have 1.00D or less of astigmatism.

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

• 2013-05-17TerminatedPackaging

  ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact lenses. The Vistakon (galyfilcon A) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00D of astigmatism or less.

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