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Terminated

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.

FDA Recall Z-1268-2015 · Posted 2015-03-13

Recalling FirmMed-logics Inc
Recall StatusTerminated
Product CodeHNO
Date Initiated2015-01-13
Date Terminated2015-10-28
Product Quantity360 units

Reason for Recall

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

Firm Action

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

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033293MED-LOGICS, MODEL ML7090Med-Logics, Inc. · 2004-01-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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