ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION
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Model Number TABLETOP |
Device Problem
Failure to Fire (2610)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The company representative confirmed and replicated the reported event.The footswitch was subsequently replaced to resolve the issue.The system was tested and found to meet product specifications.The manufacturing device history record (dhr) was reviewed.The dhr was completed and reviewed by quality assurance (qa) to ensure that the product was manufactured in compliance with the device master record.Based on qa assessment, the product met specifications before distribution.The root cause of the reported event is attributed to nonconforming footswitch.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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Event Description
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A nurse reported the laser functioned intermittently, after two or three shots, the laser was switching in stand-by mode function before performing a vitrectomy procedure.An alternative console was used and the procedure was completed.There was no patient involvement.
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Search Alerts/Recalls
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