A check of the batch production record could not be performed because the lot number was not reported.The expiration date could not be determined.A check of the complaint records could not be performed because the lot number was not provided.A check of confirmed complaints for sf6 eye gas not lasting as long in the patient's eye as expected showed no complaints.The sample was not returned.Testing could not be performed.No sample was returned for evaluation.With no additional, related information provided, the reported event was not confirmed.At this time, the root cause of the reported event cannot be determined.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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