ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR — Class II medical device recall Z-1336-2013
Terminated recall by Johnson & Johnson Vision Care, Inc., reported 2013-05-22, distributed nationwide. Limited number of individual contact lens packages may not have been completely sealed.
| Recall number | Z-1336-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Johnson & Johnson Vision Care, Inc., Jacksonville, FL, United States |
| Recall initiated | 2012-12-21 |
| Classified | 2013-05-16 |
| Reported by FDA | 2013-05-22 |
| Terminated | 2013-07-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, CR, DE, DK, ES, FR, GB, HU, IE, IL, IN, IT, JP, KR, LU, NL, NO, PT, SE, SI, ZA |
| Quantity | 3,546 lenses |
| Lot numbers | 6.00D, 7.00D, B00DJPQ, B00DMHZ, B00DMJP |
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 for recall
Limited number of individual contact lens packages may not have been completely sealed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1336-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.