Class II — Johnson & Johnson Vision Care, Inc.
| Recalling firm | Johnson & Johnson Vision Care, Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Limited number of individual contact lens packages may not have been completely sealed. |
| 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. |
| 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,… |
| Initiated | 2012-12-21 |
| Classified | 2013-05-16 |
| Terminated | 2013-07-05 |
| Recall number | Z-1336-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Johnson & Johnson Vision Care, Inc. (Z-1336-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64468/
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