ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10. ML 7090 Calibrated LASIK Blade (CLB) is to be used
FDA device recall Z-1268-2015 · posted 2015-03-13 · Terminated
Recall details
- Recalling firm
- Med-logics Inc
- Reason for recall
- The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- HNO
- Quantity affected
- 360 units
- Distribution
- Distributed in the states of CA, AL, GA, and TN, and the countries of Chile and Germany.
- Date initiated
- 2015-01-13
- Date posted
- 2015-03-13
- Date terminated
- 2015-10-28
- Location
- Athens, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MED-LOGICS, MODEL ML7090 (K033293) | Med-Logics, Inc. | 2004-01-13 |