Catalog Number 8065753057 |
Device Problem
Energy Output Problem (1431)
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Patient Problems
Fluid Discharge (2686); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/23/2022 |
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 during a cataract surgery while using an ophthalmic console patient experienced a white liquid appeared and the chamber was collapsed.Surgeon changed the ophthalmic phacoemulsification tip however the ultrasound was not working.Surgery was completed after restarting the system.Patient was recovered without giving any medication.
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Manufacturer Narrative
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The company representative (did not) confirm nor replicate anything that would have contributed to the reported event.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.A potentially relevant complaint was found and reviewed as part of this investigation.The system was found to meet specifications.Therefore, the root cause of the reported event(s) are 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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