Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-1336-2013

December 21, 2012

Class II

Product summary

Firm
Johnson & Johnson Vision Care, Inc.
Event
Event 64468
Status
Terminated
Classification
Class II
Quantity
3546 lenses
Official record key
device-enforcement:Z-1336-2013

Official wording

Reason: Limited number of individual contact lens packages may not have been completely sealed.

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Limited number of individual contact lens packages may not have been completely sealed.