The micor extractor was returned to the manufacturer and evaluated.The device was subjected to visual inspection, functional testing, and then disassembled for internal inspection.There was no damage or device defect identified and the device met specifications.The device had dried viscoelastic present inside the cutter tube (normal use condition) that prevented the device from aspirating during functional testing.There was no alleged malfunction and no device malfunction identified during the device evaluation.This conclusion is consistent with the event reported by the surgeon who attributed the capsular tear and sequelae to the surgical technique employed, which placed additional pressure on the posterior capsule and compromised the integrity.The micor extractor device history records were reviewed for this manufacturing lot and there were no discrepancies or unusual findings that relate to the reported event.Based on the information reviewed, there is no evidence to indicate the presence of a potential quality issue with respect to manufacturing, design, or labeling.The device labeling identifies capsular rupture as an inherent safety risk.Manufacturer's reference #: (b)(4).
|