Z-1336-2013Class II

ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact lenses. The Vistakon...

Name: Z-1336-2013 ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact lenses. The Vistakon...
Creator: Johnson & Johnson Vision Care, Inc.
Published: 2012-12-21
License: https://open.fda.gov/license/

Johnson & Johnson Vision Care, Inc. / initiated 2012-12-21 / Terminated / root cause: packaging

FDA source

Johnson & Johnson Vision Care, Inc. began a recall of ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact lenses. The Vistakon (galyfilcon A) Contact Lens is indicated for daily wear for... on 2012-12-21. FDA classified it as Class II and gives the reason as "Limited number of individual contact lens packages may not have been completely sealed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1336-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-21
Posted: 2013-05-17
Terminated: 2013-07-05
Recalling firm: Johnson & Johnson Vision Care, Inc.
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.
Product code: LPL Lenses, Soft Contact, Daily Wear
Reason for recall: Limited number of individual contact lens packages may not have been completely sealed.
Root cause tag: packaging
FDA root cause: Packaging
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.
Product codes and lots: Lot Codes: B00DJPQ, -7.00D B00DMHZ, -6.00D B00DMJP, +4.00D

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1336-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1335-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-16
Z-1336-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-16

Product code LPL

K062614Class IIVistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and Tinted (Visibility And/or Cosmetically)Johnson & Johnson Vision Care, Inc. / cleared 2006-11-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)