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System failed to meet the mA's accuracy specfications at low mA's values
Reports of hex driver tips breaking off or becoming worn or stripped.
Sterility barrier compromised.
Air may be introduced into this Stent system when used with certain size acessory devices.
adjustment screw may break due to material fatigue
The device is not stable throughout its labeled expiration date.
This device is not approved for sale in the US.
Sterility compromised due to lack of package seal integrity
Increased numbers of lens tears during placement of lens into eye.
mislabeled - product actually Single Valve