Med-logics Recalls ML 7090 Calibrated LASIK Blades Due to Fit Issues
Med-logics Inc is recalling 360 units of ML 7090 Calibrated LASIK Blades because they do not fit into the AMO Amadeus Metal Blade Holder.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a functional defect (incompatibility) rather than a direct safety risk like contamination or injury, and no injuries or illnesses are reported in the source text.
Plain-English summary
Med-logics Inc is recalling 360 units of the ML 7090 Calibrated LASIK Blade (CLB), specifically Lot 1490288. These blades are intended to be used as replacement blades for the AMO Amadeus Microkeratome to perform lamellar keratectomy procedures.
The recall was initiated because the ML 7090 Calibrated LASIK Blades will not fit into the AMO Amadeus Metal Blade Holder. This defect prevents the proper use of the device as intended.
The affected units were distributed in the states of California, Alabama, Georgia, and Tennessee, as well as in the countries of Chile and Germany. Users of these products should stop using the blades and contact Med-logics Inc for further instructions.
The recalled product
- 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.
- Manufacturer
- Med-logics Inc
- Hazard
- Affected units
- 360
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 1490288
Distribution
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