Additional information was provided in sections d.9, h.3, h.6 and h.10.The company representative was unable to confirm nor replicate anything that would have contributed to the reported event.However, the fluidics was returned for testing on this investigation.The system was tested and found to meet product specifications.A non-conformance-based review of the 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 serial number was performed.No similar complaints were reported for the product serial under investigation.The fluidics was received for testing on this investigation.A visual assessment of the returned sample revealed no obvious nonconformity.The returned sample was installed into a calibrated system and tested.The reported event was not replicated and there was no problem found with the sample.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.The returned sample and the system were to meet specification.Therefore, 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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