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U.S. Department of Health and Human Services

Class 2 Device Recall ML7090 Microkeratome Blade

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  Class 2 Device Recall ML7090 Microkeratome Blade see related information
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.
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