Correction: initially reported device manufacturing date from 11/1/2016 to corrected device manufacturing date august 2016.Device evaluation: a review of the records related to the device that included labeling, manuals, trending, and risk documentation was performed.The trend review shows that there is not significant change over historical complaint limits and no recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.There was no product deficiency identified.The review of the device history record (dhr) the refractive idesign showed that there were no issues or non-conformities.Manufacturing has been ruled out as a potential cause for the reported issue.No conclusive evidence identified for reported issue.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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