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U.S. Department of Health and Human Services

Class 2 Device Recall Eyemaxx MVR 20g Microsurgical Knife

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 Class 2 Recall
Eyemaxx MVR 20g Microsurgical Knife
see related information
Date Posted July 04, 2007
Recall Status1 Terminated on September 25, 2009
Recall Number Z-0998-2007
Recall Event ID 38130
Product Classification Knife, Ophthalmic - Product Code HNN
Product Eyemaxx MVR 20g Microsurgical Knife, Item #MX3020
Code Information Lot #DK1106O
Recalling Firm/
Manufacturer
Oasis Medical Inc
510-528 South Vermont Ave
Glendora, California 91741
For Additional Information Contact Robyn Scopis
626-852-5156
Manufacturer Reason
for Recall
This voluntary recall has been initiated due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control
Action Notification of the recall sent to distributors and users. The 06/08/07 letter requests customers to notify down to the user level. Included in the Recall Notification Letter are instructions: "In addition, if you may have further distributed this product, please identify your customers and notify them at once ofthis product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent any inconvenience.".
Distribution Worldwide, including USA, Switzerland, Germany, England, UK, Turkey, Czech Republic, and Lithuania.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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