Class 2 Device Recall MAGNIVISION

• Date Initiated by Firm: May 02, 2003
• Date Posted: February 24, 2004
• Recall Status: Terminated on July 07, 2012
• Recall Number: Z-0541-04
• Recall Event ID: 26331
• Product Classification: Frame, Spectacle - Product Code HQZ
• Product: Product is Magnivision UltraLights reading glasses which have the dioptic power on the label and ''MAGNIVISION AN AMERICAN GREETINGS COMPANY Miramar, FL 33025''
• Code Information: Product is not coded.
• FEI Number: 1000120742
• Recalling Firm/ Manufacturer: Magnivision, Inc.; 3700 Commerce Pkwy.; Miramar FL 33025
• For Additional Information Contact: Eleanor Chilson; 954-986-9000 Ext. 3413
• Manufacturer Reason for Recall: Possibility of eye injury from large temple tags on promotional sale product when customer tries them on in store.
• FDA Determined Cause: Other
• Action: The firm sent an e-mail dated 4/16/03 to their only direct wholesaler telling them to hold the product and followed up with a phone call infomring them of the retagging on 5/2/03 and a sufficient quantify of tags to relabel product at the retail level. Also they visited the wholesaler and retagged in house stock with the smaller tag.
• Quantity in Commerce: 145884
• Distribution: Product was distributed to a a wholesaler in Florida.
• Total Product Life Cycle: TPLC 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.