The product under investigation is not a serviceable device.Therefore, a service record review was not performed.However, there was no product returned for this investigation.Based on the information obtained, the root cause of the reported event is inconclusive.Specific product identifiers (serial number) were not provided and could not be determined at this time.However, all device history records are reviewed prior to product release to ensure the product was manufactured in compliance with the device master record and meets release criteria.A review for complaints reported against this serial number cannot be performed as the serial number is unknown.The serial is unknown.Therefore, a service history review cannot be performed.Corneal burn is an issue that is occasionally reported with cataract surgery.According to the pennsylvania patient safety advisory abstract: preventing corneal burns during phacoemulsification, march 2010, vol.7, no.1: 23-25, most corneal burns can be traced to issues related to surgical technique and not to malfunctioning equipment.Based on the information obtained, 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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