Catalog Number 8065751763 |
Device Problems
Energy Output Problem (1431); Suction Failure (4039)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/03/2023 |
Event Type
malfunction
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Event Description
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A customer reported that multiple patients experienced unstable anterior chamber while performing cataract surgery.The customer also mentioned that the phacoemulsification (phaco) power of an ophthalmic console was poor and there was no vacuum during phacoemulsification.The procedure was completed without any medical or surgical intervention.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 did not confirm nor replicate the reported event.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.No similar complaints were reported for the product serial under investigation.The root cause of the reported event was found to exhibit no functional issues.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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