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U.S. Department of Health and Human Services

Class 2 Device Recall ACUVUE ADVANCE Brand Contact Lens

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  Class 2 Device Recall ACUVUE ADVANCE Brand Contact Lens see related information
Date Initiated by Firm December 21, 2012
Date Posted May 17, 2013
Recall Status1 Terminated 3 on July 05, 2013
Recall Number Z-1336-2013
Recall Event ID 64468
510(K)Number K062614  
Product Classification Lenses, soft contact, daily wear - Product Code LPL
Product 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.
Code Information Lot Codes: B00DJPQ, -7.00D B00DMHZ, -6.00D B00DMJP, +4.00D
Recalling Firm/
Johnson & Johnson Vision Care, Inc.
7500 Centurion Pkwy
Jacksonville FL 32256-0517
For Additional Information Contact Customer Service
Manufacturer Reason
for Recall
Limited number of individual contact lens packages may not have been completely sealed.
FDA Determined
Cause 2
Action The firm, Johnson & Johnson, Vision Care, Inc. sent a letter dated January 9, 2013 to all their consignees stating the following actions: " Please contact your patients that may have received any of the affected product and instruct them to discontinue use immediately and return product to you for replacement " Please return the enclosed Business Reply Card (BRCl confirming for our records that you have received this notice, and indicating whether or not you have in stock, or have distributed to patients, any product from the lots noted above. " Please return any remaining affected product in your possession using the enclosed pre-paid mailer. " Pass this notice on to anyone in your practice that needs to be informed " Customer service will arrange for the return and replacement of any affected product. If you have any questions and/or if replacement lenses are needed, please contact customer Service (1-800-87 4-5278).
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LPL and Original Applicant = JOHNSON & JOHNSON VISION CARE, INC.