The phaco handpiece was not returned for evaluation.The phaco handpiece manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.With no additional, related information provided, the customer reported events could not be confirmed.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 upon the information provided the root cause of the reported event cannot be determine conclusively.The manufacturer internal reference number is: (b)(4).
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