Z-1557-2011

AquaRefresh, Multi-Purpose Solution, 2 fl.oz/60mL, Made in the Netherlands, Distributed by Marietta Vision...

Name: Z-1557-2011 AquaRefresh, Multi-Purpose Solution, 2 fl.oz/60mL, Made in the Netherlands, Distributed by Marietta Vision...
Creator: Marietta Vision
Published: 2011-02-21
License: https://open.fda.gov/license/

Orion Vision / initiated 2011-02-21 / Terminated / root cause: labeling and UDI

FDA source

Marietta Vision began a recall of AquaRefresh, Multi-Purpose Solution, 2 fl.oz/60mL, Made in the Netherlands, Distributed by Marietta Vision, 397 N. Sessions Street, Marietta, GA 30060. Contact... on 2011-02-21. The reason FDA records is "Product is misbranded; Product labeled as, Made in the Netherlands, was actually manufactured in Mexico". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1557-2011
Status: Terminated
Initiated: 2011-02-21
Posted: 2011-03-04
Terminated: 2011-11-03
Recalling firm: Orion Vision
Product: 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
Product code: LPN Accessories, Soft Lens Products
Reason for recall: Product is misbranded; Product labeled as, Made in the Netherlands, was actually manufactured in Mexico.
Root cause tag: labeling and UDI
FDA 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 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 commerce: 500/2 fl.oz. Bottles
Distribution: Nationwide Distribution including AR, AZ, CA and TX.
Product codes and lots: Lot Number: KD005

Product code LPN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)