Recall Z-1335-2013— Johnson & Johnson Vision Care, Inc.
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: 1-DAY ACUVUE MOIST Brand Contact Lenses, soft disposable contact lenses. The Vistakon (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically), with UV Blocker for Daily Disposable Wear (spherical) is indicated for daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with not diseased eyes who may have 1.00D or less of astigmatism.. 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 recordK-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
1-DAY ACUVUE MOIST Brand Contact Lenses, soft disposable contact lenses. The Vistakon (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically), with UV Blocker for Daily Disposable Wear (spherical) is indicated for daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with not diseased eyes who may have 1.00D or less of astigmatism.
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.