Recall Z-1336-2013— Johnson & Johnson Vision Care, Inc.

Name: FDA recall Z-1336-2013
Creator: U.S. Food and Drug Administration
Published: 2012-12-21

Class II · Terminated

Class II FDA medical device recall by Johnson & Johnson Vision Care, Inc., initiated 2012-12-21, terminated 2013-07-05. It names one FDA 510(k) clearance: K062614. 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.. Reason: Limited number of individual contact lens packages may not have been completely sealed..

Recalling firm: Johnson & Johnson Vision Care, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-12-21
Terminated: 2013-07-05
Firm location: Jacksonville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K062614 — VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY)Johnson & Johnson Vision Care, Inc.·cleared 2006-11-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.