Med-logics Inc recalls ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10. ML 7090 Calibrated LASIK Blade (CLB) is to be used…

Recall date

January 13, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1268-2015

FDA classification

Class II

Brand / firm

Med-logics Inc

Sold / distributed

Distributed in the states of CA, AL, GA, and TN, and the countries of Chile and Germany.

Why it was recalled

The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.