ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER INFINITI VISION SYSTEM; UNIT, PHACOFRAGMENTATION
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Model Number V3.0 JAPAN |
Device Problems
No Display/Image (1183); Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/15/2022 |
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 physician reported that an ophthalmic console screen was turned black and restarted automatically during irrigation aspiration use.The surgery was completed successfully.The patient impact was not reported.No further information expected as customer was unwilling to provide.
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Manufacturer Narrative
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The company representative confirmed the reported event.However, they were unable to replicate the reported issue.The system was tested and found to meet product specifications.A non-conformance-based review of the batch/lot/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 lot/batch/serial number was performed.No similar complaints were reported for the product lot/batch/serial under investigation.The system was found to have no problem.Therefore, 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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