Additional information: the device was not available; therefore, product testing on the actual device could not be performed.The device history record review of the manufacturing lot was performed and there were no non-conformities found to be related to the reported event.A review of the device labeling was completed.Malpositioned stent is identified in the labeling as a known inherent risk of trabecular micro-bypass stent procedure.The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device.An adverse event appears to have occurred, but does not appear to have been a problem with the device or the way it was used.Malpositioned stent is an established risk associated with use of the device, which is clearly specified in the product''s labeling.Based on the information received, the root cause of the reported event could not be conclusively identified.Mfr# reference:(b)(4).
|
It was reported that following a left eye (os) cataract surgery, during an attempt to implant a stent from a trabecular microbypass stent system, the stent was observed "free floating" in the vitreous.Reportedly, the procedure was completed using a back-up device to implant all stents "properly and in place." per report, the surgeon initially requested a medical consultation to discuss treatment options for the mispositioned stent but subsequently declined.Additional information has been requested.
|