The device was not returned for evaluation.A review of the device history record (dhr) did not find any non-conformities or anomalies related to the reported event.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, 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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