It was reported one day after implantation of an intraocular lens into the left eye (os) the lens rotated out of position.Approximately one-month post-op, the iol was repositioned to its intended position.In the surgeon''s opinion, the cause of the iol rotation is unknown.Patient outcome is good.
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The lens remains implanted and is not available for investigation.A review of the device history record (dhr) did not identify any anomalies or nonconformities that could be related to this event.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause of this event could not be conclusively determined.
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