Model Number V3.0 |
Device Problem
Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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 an ophthalmic console froze.Procedure details and patient impact were not reported.Additional information has been requested none received till date.Additional information received and indicated that the planned procedure was cataract and the procedure was completed using a backup system.There was no impact on the patient.
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Manufacturer Narrative
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The company representative confirmed/replicated the reported event.The central processing unit (cpu) host module was subsequently replaced to address 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 root cause of the reported event is attributed to the nonconforming cpu 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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