Z-1268-2015 Class II Terminated
FDA device recall Z-1268-2015 was initiated by Med-logics Inc on January 13, 2015 and is designated Class II. Reason for recall: The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder. The recall status is terminated (terminated October 28, 2015). Affected quantity: 360 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 25, 2015
- Initiation Date
- January 13, 2015
- Termination Date
- October 28, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 360 units
Product Description
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.
Reason for Recall
The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder.
Distribution Pattern
Distributed in the states of CA, AL, GA, and TN, and the countries of Chile and Germany.
Code Information
Lot 1490288