Recall Z-2445-2010 ยท LPM Lenses, Soft Contact, Extended Wear
Vistakon
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 be
| Date | Sep 21, 2010 (initiated Jul 16, 2010) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Error in labeling |
| 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 inst |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.