The customer reported that the system cutter didn't actuate.The reported event occurred during surgery.Patient impact was reported.The company service representative examined the system and was unable to confirm or replicate the reported event.As a preventative measure, the pneumatics module was replaced.The system was then tested and met all product specifications.A system 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.The system was found to have no problem; therefore, the root cause of the reported event cannot be determined conclusively.Alcon 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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