ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM; UNIT, PHACOFRAGMENTATION
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Catalog Number 8065751763 |
Device Problem
Increase in Pressure (1491)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/07/2023 |
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 during a cataract procedure an ophthalmic console was producing too much pressure.Procedure was completed by restarting the system, changed to new tubing, re-primed, and tuned phacoemulsification handpiece.There was no patient impact reported.
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Manufacturer Narrative
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The company representative was able to resolve the reported event remotely with the customer.Therefore, the system was not tested on-site.Based on the information obtained, the root cause of the reported event is inconclusive.A non-conformance based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.A 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 serial number was performed.No similar complaints were reported for the product serial under investigation.Based on the information obtained, the root cause of the reported event is inconclusive.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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Search Alerts/Recalls
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