Recall Z-1268-2015 ยท HNO Keratome, Ac-Powered
Med-logics Inc
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.
| Date | Mar 13, 2015 (initiated Jan 13, 2015) |
| Status | Terminated |
| Reason | The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder. |
| Root cause | 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 | 360 units |
| Distribution | Distributed in the states of CA, AL, GA, and TN, and the countries of Chile and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033293 | MED-LOGICS, MODEL ML7090 Med-Logics, Inc., Jan 13, 2004 |