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 for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with not diseased eyes who may have 1.00D or less of astigmatism.
This recall has been terminated (originally issued January 12, 2012).
- Recall Initiated
- December 1, 2011
- Posted
- January 12, 2012
- Terminated
- June 18, 2012
- Recall Number
- Z-0734-2012
- Quantity
- 152 cartons
- Firm Location
- Jacksonville, FL
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
External carton Lot Number B00BVTN -1.50 -1.25cyl. 100¿ (30 primary packages per secondary carton Internal package Lot Number B00BSBH -1.75 -0.75cyl. 80¿ (30 primary packages per secondary carton)
Root Cause
Employee error
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.