Recall Z-1268-2015— Med-logics Inc
Class II · Terminated
Class II FDA medical device recall by Med-logics Inc, initiated 2015-01-13, terminated 2015-10-28. It names one FDA 510(k) clearance: K033293. 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.. Reason: The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder..
- Recalling firm
- Med-logics Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-01-13
- Terminated
- 2015-10-28
- Firm location
- Athens, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.