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
|
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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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