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Z-1336-2013 Class II Terminated

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

FDA device recall Z-1336-2013 was initiated by Johnson & Johnson Vision Care, Inc. on Dec 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 Jul 5, 2013). Affected quantity: 3546 lenses.

Recall Details

Product Type: Devices
Report Date: May 22, 2013
Initiation Date: Dec 21, 2012
Termination Date: Jul 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

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