Recall Z-0734-2012 ยท MVN Lens, Contact, (Disposable)
Johnson & Johnson Vision Care, Inc.
Outer Carton labeled in part:" 1-DAY ACUVUE MOIST BRAND CONTACT LENSES WITH LACREON FOR ASTIGMATISM***Contact Lenses for Daily Wear***D -1.50***-1.25 100***2016/07***BC 8.5***DIA 14.5***Made in USA***LOT B00BVTN0VS***" Individual Lenses labeled in part: "***1-DAY ACUVUE MOIST FOR ASTIGMATISM WITH LACREON***BC 8.5***DIA 14.5***AXIS -1.75 -0.75***080***2016/06***LOT B00BSBH***" It is intended fo
| Date | Jan 12, 2012 (initiated Dec 1, 2011) |
| Status | Terminated |
| Reason | Johnson & Johnson Vision Care, Inc. recalled their 1-DAY ACUVUE MOIST Brand Contact Lenses for ASTIGMATISM due to a lot being mixed. The secondary carton lot number and power are not the same as on the primary package inside the carton. |
| Root cause | Employee error |
| Action | The firm, Johnson & Johnson Vision Care, sent an "IMPORTANT PRODUCT NOTIFICATION" letter dated 1 December 2011 to all consignees/customers. The letter describes the product, problem and actions to be taken. The customers were instructed to check their practice/store inventory for product affected by this discrepancy in labeling; if you dispensed this product to a patient; contact the patient and replace lenses to all intended visual correction and performance with the correct lens power; complete and return ACKNOWLEDGEMENT OF RECEIPT Form via fax to: 904-443-3442 or email: VPIWEB@visus.jn.com |
| Quantity | 152 cartons |
| Distribution | Worldwide distribution: USA (nationwide) including states of: NY and FL and countries of: Finland, France, Germany, Italy, Netherlands, Norway, Denmark, Switzerland, Sweden, and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051900 | ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR Johnson & Johnson Vision Care, Inc., Aug 12, 2005 |