The company service representative (ar), examined the system and was able to replicate the reported events.The company service representative replaced the nonconforming host module to resolve the issue of frozen screen.The xenon lamp was replaced to resolve the exceeded lamp.A review of the system¿s event log from the time of the reported event revealed that system message (sm).The system message is an advisory for the user to replace the lamp, after it has reached 400 hours.And may be cleared by the user pressing a button on the screen.The lamp can still be used after this system message is acknowledged.The phacoemulsification handpiece was replaced to resolve, the handpiece issue.The system was then tested.And met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to the nonconforming host module, and nonconforming phacoemulsification handpiece.The root cause of the reported event can be attributed to the xenon lamp.Which exceeded its rated life.However, no problem was found, with the xenon lamp as it functioned to its expected rated life.The manufacturer internal reference number is: (b)(4).
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