Additional narrative information: age at time of event: unknown.Date of birth and gender: unknown.Patient weight: unknown.Ethnicity and race: unknown.Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: a review of the device history record (dhr) showed that there were no discrepancies or non-conformances experienced during manufacturing.The system and its components met all specifications prior to being released.A review of the records related to this equipment that included labeling, manual, trending, and risk documentation reviews was performed.Conclusion: based on the investigation results there is no indication of a product quality deficiency.Equipment labeling provides possible complications that can be caused by the surgical/treatment procedure being performed.The trend review shows that 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.There was no product deficiency identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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