CLASS II Device recall · Reported 22 May 2013 · FDA Enforcement Report
Acuvue Advance Contact Lenses with Hydraclear, Soft recalled
Johnson & Johnson Vision Care is recalling Acuvue Advance Contact Lenses with Hydraclear, Soft, disposable contact lenses, distributed nationwide in the US. The recall was initiated on 21 Dec 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1336-2013
- FDA event ID
- 64468
- Recalling firm
- Johnson & Johnson Vision Care, Jacksonville, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Dec 2012
- FDA classified
- 16 May 2013
- Reported
- 22 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Contact Lenses & Eye Devices
Timeline
| 21 Dec 2012 | Recall initiated by company | |
| 16 May 2013 | Classified by FDA | +146 days |
| 22 May 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Limited number of individual contact lens packages may not have been completely sealed.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMichiganMissouriNorth CarolinaNew JerseyNew York
Questions about this recall
Why was it recalled?
Limited number of individual contact lens packages may not have been completely sealed.
Which lots are affected?
Lot Codes: B00DJPQ, -7.00D B00DMHZ, -6.00D B00DMJP, +4.00D
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 64468| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | 1-Day Acuvue Moist Contact Lenses, soft disposable contact lenses recalled | Johnson & Johnson Vision Care | Packaging Defects | Nationwide |
More recalls from Johnson & Johnson Vision Care
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Acuvue¿ Oasys Max 1-Day Multifocal recalled | Johnson & Johnson Vision Care | Device Malfunction | Nationwide |
| Device | CLASS II | Acuvue Vita soft (hydrophilic) contact lens (spherical) recalled | Johnson & Johnson Vision Care | Packaging Defects | Nationwide |
| Device | CLASS II | Acuvue Oasys for Astigmatism Contact Lenses recalled | Johnson & Johnson Vision Care | Packaging Defects | Nationwide |
| Device | CLASS II | Acuvue Oasys for Astigmatism contact lenses recalled | Johnson & Johnson Vision Care | Packaging Defects | CA |
| Device | CLASS II | 1-Day Acuvue Moist Daily Wear, 8.5 Base Curve, -3.25 Power recalled | Johnson & Johnson Vision Care | Packaging Defects | Nationwide |
Other Contact Lenses & Eye Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Tecnis Eyhance Iol with Tecnis Simplicity" Delivery System recalled | AMO Puerto Rico Manufacturing | Device Malfunction | Nationwide |
| Device | CLASS II | Alcon PRECISION1 One-Day Contact Lenses, -2.25D recalled | Alcon Research | Sterility | 19 states |
| Device | CLASS II | Sofmed Breathables, (stenfilcon A) contact lens recalled by CooperVision | CooperVision | Sterility | Nationwide |
| Device | CLASS II | Voyant 1-Day Premium Toric, (stenfilcon A) contact lens recalled | CooperVision | Sterility | Nationwide |
| Device | CLASS II | MyDay Toric, stenfilcon A) Contact Lens recalled by CooperVision | CooperVision | Sterility | Nationwide |