Device 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.
Z-1268-2015
Product summary
- Firm
- Med-logics Inc
- Event
- Event 70348
- Status
- Terminated
- Classification
- Class II
- Quantity
- 360 units
- Official record key
device-enforcement:Z-1268-2015
Official wording
Reason: The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder.
Code information: Lot 1490288
Distribution pattern: Distributed in the states of CA, AL, GA, and TN, and the countries of Chile and Germany.
Derived failure modes
-
Unknown
The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder.