Z-1336-2013 Class II Terminated

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

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
3546 lenses

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.

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 Codes: B00DJPQ, -7.00D B00DMHZ, -6.00D B00DMJP, +4.00D