Visual inspection of the retuned lens found the plate damaged (tears and damaged haptic).Further testing could not be performed due to the condition of the returned lens.One retain sample from the same lot (7546117) was dimensionally inspected and all measurements were within specification.The device history records were reviewed and there were no discrepancies or unusual findings that relate to the reported issue.Based on the information available, the exact cause of the reported event could not be conclusively determined.However, it is possible that 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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