Recall Z-1557-2011 ยท LPN Accessories, Soft Lens Products
Marietta Vision
AquaRefresh, Multi-Purpose Solution, 2 fl.oz/60mL, Made in the Netherlands, Distributed by Marietta Vision, 397 N. Sessions Street, Marietta, GA 30060. Contact lens solutions used to clean, rinse, disinfect, rewet and store all soft contact lenses
| Date | Mar 4, 2011 (initiated Feb 21, 2011) |
| Status | Terminated |
| Reason | Product is misbranded; Product labeled as, Made in the Netherlands, was actually manufactured in Mexico. |
| Root cause | Other |
| Action | John Patterson, President of Marietta Vision called each optical retailer on February 21, 2011, and told them of the misbranding issue in regards to country of origin. In addition, an Urgent Product Recall letter was sent to each account on February 23, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their AquaRefresh inventory for lot number KD005, and discontinue distribution of the samples immediately and to return any outstanding stock to Marietta Vision for exchange. Marietta Vision would return the mi |
| Quantity | 500/2 fl.oz. Bottles |
| Distribution | Nationwide Distribution including AR, AZ, CA and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.