Primary (inner) Package Label: ACUVUE OASYS BRAND CONTACT LENSES for ASTIGMATISM with HYDRACLEAR Plus (senofilcon A) Joh

FDA device recall Z-2445-2010 · posted 2010-09-21 · Terminated

Recall details

Recalling firm

Vistakon

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

Action taken

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

Status

Terminated

Product code

LPM

Quantity affected

2,123 lenses

Distribution

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

Date initiated

2010-07-16

Date posted

2010-09-21

Date terminated

2011-03-28

Location

Jacksonville, FL