Service history was reviewed for the system.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) opened.The system found to meet all cosmetic and performance standards.Based on the information obtained, the root cause of the reported event is inconclusive.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 non-conformance-based review of the serial number was performed and a potential contributing factor to the reported complaint was identified.An internal investigation was opened to address the issue.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation.Posterior capsule tear is an issue that is occasionally reported with cataract surgery.However, a review of the complaint trends shows that the frequency reported is within known levels for this event.A root cause cannot be determined conclusively.Based on the information obtained, the root cause of the reported event is inconclusive.Manufacturers 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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