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Terminated

Primary (inner) Package Label: ACUVUE OASYS BRAND CONTACT LENSES for ASTIGMATISM with HYDRACLEAR Plus (senofilcon A) Johnson & Johnson Vision Care, Inc. Rx Only, STERILE. Lot B006WBS1 -9.00D -1.25 CYL 80 , 2013/05 AXIS. (Correct labeling) Mislabeled Outer (secondary) Label: Lot B006X641 D -8.50 CYL -1.25 AXIS 100, 2013/05 DO NO PAY Free Sample Not For Sale Consumer Note: This product has been provided free of charge to your Eye Care professional to aid in proper fitting. The sale of this product is prohibited. You should not have been charged money for this product. Contents: 1 lens (38% H2) in buffered saline with up to 0.005% methyl ether cellulose.

FDA Recall Z-2445-2010 · Posted 2010-09-21

Recalling FirmVistakon
Recall StatusTerminated
Product CodeLPM
Date Initiated2010-07-16
Date Terminated2011-03-28
Product Quantity2,123 lenses

Reason for Recall

ACUVUE OASYS Brand Contact Lenses for ASTIGMATISM may be mislabeled on the outer (secondary) packaging carton. The outer (secondary) cartons labeled as Lot B006X641 -8.50D -1.25cyl. 100 Axis may actually contain primary packages from Lot B006WBS1 -9.00D -1.25cyl. 80 Axis. The inner (primary) package labeling is correct. Product was only distributed to Eye Care Professionals for use in proper f

Firm Action

Vistakon issued an Important Product Notification dated July 28, 2010 to customers identifying the affected product, the labeling issue, and actions to be taken by the customer. Vistakon issued a separate Important Product Notification dated July 28, 2010 to distribuitors identifying the affected product, the labeling issue, and actions to be taken by the distributor. Customers are instructed to check their inventory for affected products and return a business reply card. If replacement -8.50 lenses are needed, the customer can contact Customer Service at 1-800-874-5178. Distributors are instructed to check their inventory for affected products and return them using an enclosed return label. Replacement product will be sent by the firm. Customer Service can be contacted at 1-800-874-5178. Accounts will be instructed to go to their inventory and look for the B006X641, -8.50 lot and open the secondary carton and verify the product inside. If it is the -9.00 product they can keep the product and re-slot it in the proper place within the kit (product is ok, nothing wrong with primary package or lens inside) and order a replacement -8.50 if necessary. Business reply cards will be supplied for accounts to return to third party indicating if they had any mix/mislabeled product.

Root Cause

Error in labeling

Distribution Pattern

Worldwide Distribution: USA including all states, District of Columbia and Puerto Rico, and the countries of Canada, Bahamas, Honduras, and United Arab Emirates.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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