ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION
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Model Number TABLETOP |
Device Problems
Operating System Becomes Nonfunctional (2996); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/29/2022 |
Event Type
malfunction
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Event Description
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A healthcare professional reported that an ophthalmic system got blocked and a noise was heard.Procedure details and patient impact were not been provided.Additional information was requested.Additional information received indicated that the event happened when the computer was switched on, computer crashed due to a problem with the computer hard disk internal part of the computer.There was no patient impact reported.
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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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Manufacturer Narrative
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Additional information is provided in section d.9, h.3, h.6 and h.10.The company representative was able to replicate the reported event.The host module was replaced to address the 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 root cause of the reported event is attributed to the non-conforming host module.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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