The customer did not retain the product lot information for this custom pak, therefore the device history records traceable to the reported procedure pack could not be reviewed.The customer reported that some of the cannulas in their paks have come off the end under the force of injecting liquid.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.When this type of issue occurs, a sample will need to be returned so that a proper investigation can be conducted.If possible, the customer should provide alcon with a photo of the cannula they received in order to help with the investigation of the issue.A sample was not returned; therefore, the root cause for the customer reported event cannot be determined.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.All lots are verified that all required inspections have been performed and all acceptance criteria are met prior to release.Quality assurance has reviewed this complaint and 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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