Z-1268-2015 Class II Terminated

Recalled by Med-logics Inc — Athens, TX

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