ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact lenses. The Vist...
FDA Recall #Z-1336-2013 — Class II — December 21, 2012
Product Description
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.
Reason for Recall
Limited number of individual contact lens packages may not have been completely sealed.
Recalling Firm
Johnson & Johnson Vision Care, Inc. — Jacksonville, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3546 lenses
Distribution
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 Codes: B00DJPQ, -7.00D B00DMHZ, -6.00D B00DMJP, +4.00D
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated