Catalog Number 8065751763 |
Device Problem
Decrease in Suction (1146)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/09/2024 |
Event Type
malfunction
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Event Description
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A physician reported that during surgery, an ophthalmic console has poor aspiration in phacoemulsification mode and ia mode.The surgery was performed and completed as it was.Patient impact have not been provided.
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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 unable to 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 non-conformance based review of the batch/lot/serial number was performed and did not reveal a contributing factor.A review for complaints reported against this serial number was performed.Another investigation was opened for a similar issue to this reported event and root cause was inconclusive.The system was found to functionally exhibit no problems; 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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