Outer Carton labeled in part:" 1-DAY ACUVUE MOIST BRAND CONTACT LENSES WITH LACREON FOR ASTIGMATISM***Contact Lenses for

FDA device recall Z-0734-2012 · posted 2012-01-12 · Terminated

Recall details

Recalling firm

Johnson & Johnson Vision Care, Inc.

Reason for recall

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.

Action taken

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 and return any cartons labeled with the noted lot number to Customer Relations. Johnson & Johnson will replace them with the correct product. For any questions regarding this labeling situation, contact Customer Relations at 1-800-843-2020.

Root cause

Employee error

Status

Terminated

Product code

MVN

Quantity affected

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.

Date initiated

2011-12-01

Date posted

2012-01-12

Date terminated

2012-06-18

Location

Jacksonville, FL

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