| 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
|
|---|
