The system was examined and the company representative was unable to replicate anything that would¿ve contributed to the reported event.The system was tested and found to meet product specifications.The manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The system was found to meet specifications.Therefore, the root cause of the reported event cannot be determined conclusively.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.The manufacturer internal reference number is: (b)(4).
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