CLASS II Device recall · Reported 25 Mar 2015 · FDA Enforcement Report
ML 7090 Calibrated Lasik Blade (CLB) recalled by Med-logics
Med-logics is recalling ML 7090 Calibrated Lasik Blade (CLB), distributed in Alabama, California, Georgia, Tennessee. The recall was initiated on 13 Jan 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1268-2015
- FDA event ID
- 70348
- Recalling firm
- Med-logics, Athens, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Jan 2015
- FDA classified
- 13 Mar 2015
- Reported
- 25 Mar 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 13 Jan 2015 | Recall initiated by company | |
| 13 Mar 2015 | Classified by FDA | +59 days |
| 25 Mar 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
Distributed in the states of CA, AL, GA, and TN, and the countries of Chile and Germany.
Questions about this recall
Is ML 7090 Calibrated Lasik Blade (CLB) recalled?
Yes. Med-logics recalled ML 7090 Calibrated Lasik Blade (CLB) on 13 Jan 2015. The recall is Class II and its status is Terminated. Recall number Z-1268-2015.
Why was it recalled?
The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder.
Which lots are affected?
Lot 1490288
Where was it sold?
Distributed in the states of CA, AL, GA, and TN, and the countries of Chile and Germany.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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