Date Initiated by Firm |
January 13, 2015 |
Date Posted |
March 13, 2015 |
Recall Status1 |
Terminated 3 on October 28, 2015 |
Recall Number |
Z-1268-2015 |
Recall Event ID |
70348 |
510(K)Number |
K033293
|
Product Classification |
Keratome, ac-powered - Product Code HNO
|
Product |
ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10.
ML 7090 Calibrated LASIK Blade (CLB) is to be used as replacement blades for the AMO Amadeus Microkeratome, to perform lamellar keratectomy procedures. |
Code Information |
Lot 1490288 |
Recalling Firm/ Manufacturer |
Med-logics Inc 1627 Enterprise St Athens TX 75751-8839
|
For Additional Information Contact |
949-582-3891
|
Manufacturer Reason for Recall |
The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder.
|
FDA Determined Cause 2 |
Process design |
Action |
The firm notified their consignees by letter on 1/13/15, sent via FedEx. The US customers were instructed to return any remaining product to MED-LOGICS and complete the response form. |
Quantity in Commerce |
360 units |
Distribution |
Distributed in the states of CA, AL, GA, and TN, and the countries of Chile and Germany. |
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 = HNO and Original Applicant = MED-LOGICS, INC.
|