Home / Recalls / Johnson & Johnson Vision Care, Inc. / Z-1335-2013

Z-1335-2013 Class II Terminated

Recalled by Johnson & Johnson Vision Care, Inc. — Jacksonville, FL

FDA device recall Z-1335-2013 was initiated by Johnson & Johnson Vision Care, Inc. on December 21, 2012 and is designated Class II. Reason for recall: Limited number of individual contact lens packages may not have been completely sealed. The recall status is terminated (terminated July 5, 2013). Affected quantity: 36,330 lenses.

Recall Details

Product Type: Devices
Report Date: May 22, 2013
Initiation Date: December 21, 2012
Termination Date: July 5, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 36,330 lenses

Product Description

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.

Reason for Recall

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

Distribution Pattern

Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and Puerto Rico; and countries of: Austria, Belgium, Canada, Costa Rica, Denmark, France, Germany, Hungary, India, Ireland, Israel, Italy, Korea, Japan, Luxembourg, Netherlands, Portugal, Norway, South Africa, Slovenia, Spain, Sweden, and United Kingdom.

Code Information

Lot Numbers: 2054890422, +2.25D 2054890521, + 2.25D 2054895620, + 2.25D 1536500620, -3.75D 2138800422, -4.75D

Other recalls by Johnson & Johnson Vision Care, Inc.

Z-2163-2025 Class II — ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL (June 12, 2025)
Z-1865-2021 Class II — ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Cu (May 6, 2021)
Z-1131-2019 Class II — ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Pow (March 11, 2019)
Z-2916-2018 Class II — Johnson and Johnson Vision Care 1-Day ACUVUE MOIST Daily Wear, 8.5 Base Curve, - (July 23, 2018)
Z-1744-2020 Class II — ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve (December 18, 2017)
Z-1210-2018 Class II — ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR (October 19, 2017)
Z-1209-2018 Class II — ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS (October 19, 2017)
Z-1211-2018 Class II — 1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses (October 19, 2017)
Z-1336-2013 Class II — ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact le (December 21, 2012)