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U.S. Department of Health and Human Services

Class 3 Device Recall AquaRefresh

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 Class 3 Device Recall AquaRefreshsee related information
Date Initiated by FirmFebruary 21, 2011
Date PostedMarch 04, 2011
Recall Status1 Terminated 3 on November 03, 2011
Recall NumberZ-1557-2011
Recall Event ID 58008
Product Classification Accessories, soft lens products - Product Code LPN
ProductAquaRefresh, 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
Code Information Lot Number: KD005
Recalling Firm/
Manufacturer		 Marietta Vision
397 N Sessions St Nw
Marietta GA 30060-1325
For Additional Information ContactJohn M. Patterson
678-797-1099
Manufacturer Reason
for Recall		Product is misbranded; Product labeled as, Made in the Netherlands, was actually manufactured in Mexico.
FDA Determined
Cause 2		Other
ActionJohn 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 misbranded product back to the Mexican factory at their expense to have the product packaging corrected. If they elect not to do so, Marietta Vision would have the product disposed of. Customers were instructed to fax the enclosed form back to Marietta Vision at 678-797-1099. For questions regarding this recall call 866-300-6257.
Quantity in Commerce500/2 fl.oz. Bottles
DistributionNationwide Distribution including AR, AZ, CA and TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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