Z-1268-2015Class II

ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10. ML 7090 Calibrated LASIK Blade (CLB) is...

Name: Z-1268-2015 ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10. ML 7090 Calibrated LASIK Blade (CLB) is...
Creator: Med-logics Inc
Published: 2015-01-13
License: https://open.fda.gov/license/

Med-logics Inc / initiated 2015-01-13 / Terminated / root cause: manufacturing process

FDA source

Med-logics Inc began a recall of 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... on 2015-01-13. FDA classified it as Class II and gives the reason as "The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1268-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-13
Posted: 2015-03-13
Terminated: 2015-10-28
Recalling firm: Med-logics Inc
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.
Product code: HNO Keratome, Ac-Powered
Reason for recall: The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder.
Root cause tag: manufacturing process
FDA root cause: Process design
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.
Quantity in commerce: 360 units
Distribution: Distributed in the states of CA, AL, GA, and TN, and the countries of Chile and Germany.
Product codes and lots: Lot 1490288

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1268-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1268-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-25	2015-03-13

Product code HNO

K033293Class IMed-Logics, Model Ml7090Med-Logics, Inc. / cleared 2004-01-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)