ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION
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Model Number TABLETOP |
Device Problems
Power Problem (3010); Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A customer reported that an ophthalmic operating console presented a power surge which caused the console to shut down during set up of a surgery.The console did not present any system message and the surgery was completed successfully after re-starting the console.There was no patient harm reported.
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Manufacturer Narrative
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The company service representative examined the system and replicated the reported event.To resolve the issue, the nonconforming power cord was replaced.Unrelated to the reported event, the company service representative replaced pneumatic module.The system was then tested and met all product specifications.A system manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this lot/batch/serial number was performed.A potentially relevant complaint was found (b)(4) and reviewed as part of this investigation.The complaint(s) was determined to not be relevant to this investigation.The root cause of the reported event is attributed to nonconforming power cord.Manufacture 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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Search Alerts/Recalls
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