Pt info: unknown/ not provided.Establishment name: unknown/not provided.Initial reporter telephone number: (b)(6).Device evaluation: a field service specialist visited the account and was able to complete a system service checklist.System met johnson & johnson surgical vision (jjsv) specifications.No problem found with system.Successfully completed prime tune for 2 units of hand piece owned by user without any error.Manufacturing record review: a record review was performed.A product deficiency review was performed and there is no product deficiency identified.A document, lot history, and trending were reviewed.There is not a 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.The review of the device history record (dhr) for the patient interface showed that there were no issues or non-conformities.The device and its components met all specifications prior to being released.Manufacturing has been ruled out as a potential cause for the reported issue.Based on the investigation results, no corrective action has been issued.Conclusion: based on the information obtained, product malfunction and product deficiency cannot be confirmed.No further investigation is required.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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