According to the reporter, the device was discarded and is not available for evaluation.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.A review of the device history record (dhr) did not find any anomalies or non-conformities related to this event.Based on the available information, the root cause of this event could not be conclusively determined; however, user related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have contributed to the event.
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