No service record relevant to the complaint reported event was found.However, the system was last serviced prior to the reported event per service record (sr).The system found to meet all cosmetic and performance standards per the service test procedure (stp)."a system non-conformance based review of the batch/lot/serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this lot/batch/serial number was performed.A potentially relevant complaint was found and reviewed as part of this investigation.A complaint was opened to address a second case that the customer reported in which anterior chamber was shallow, vitreous loss occurred, and infusion was not flowing out of the i/a tips freely.The pr is in progress at the time of this investigation.The root cause of the reported event is inconclusive.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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