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U.S. Department of Health and Human Services

Class 2 Device Recall Cornea Power Kit (software)

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  Class 2 Device Recall Cornea Power Kit (software) see related information
Date Initiated by Firm February 21, 2012
Date Posted March 30, 2012
Recall Status1 Terminated 3 on April 02, 2012
Recall Number Z-1340-2012
Recall Event ID 61373
510(K)Number K111505  
Product Classification Tomography, optical coherence - Product Code OBO
Product RTVue CAM with Corneal Power Measurement, Cornea Power Kit (software)
Code Information Serial numbers: 12797, 12749, 12788, 12790, 12745, 12614, 12771, 11901R1.
Recalling Firm/
Manufacturer
Optovue Inc.
45531 Northport Loop W
Fremont CA 94538-6417
For Additional Information Contact John Talerico
510-623-8868 Ext. 209
Manufacturer Reason
for Recall
A few doctors in the US were inadvertently sent the Cornea Power software version kit for international users instead of the domestic version.
FDA Determined
Cause 2
Employee error
Action Field Correction letters were sent to all doctors affected by the issue on February 23, 2012. The letter identified the affected product and the problem. The letter also stated that customers may continue to use the RTVue until the correction was made. Once the correction has been made, customers are to sign and return the attached acknowledgement form. If customers had questions, they are to contact Optovue at 1-866-344-8948 or via mail at 45531 Northport Loop W, Fremont, CA 94538.
Quantity in Commerce 8
Distribution Nationwide Distribution -- CA and WA only
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.
510(K) Database 510(K)s with Product Code = OBO and Original Applicant = OPTOVUE, INC.
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