Catalog Number 8065751763 |
Device Problems
Defective Component (2292); Operating System Becomes Nonfunctional (2996)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/17/2023 |
Event Type
malfunction
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Event Description
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A customer reported that during a cataract procedure an ophthalmic operating console was stopped working.There were system messages displayed and the balanced salt solution (bss) door could not open completely.The machine was restarted and removed the bag.An extracapsular cataract extraction method then used to completed the surgery without the use of the operating console.There was no patient harm.
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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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The company representative was able to replicate the reported event.The fluidics module and reloading the software were both replaced to address the issue.The system was tested and found to meet product specifications.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.A potentially relevant complaint was found and reviewed as part of this investigation.Based on the information obtained, the root cause of the reported event is attributed to the fluidics 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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