Catalog Number 8065753057 |
Device Problems
Decrease in Suction (1146); Failure to Cut (2587)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/23/2024 |
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 during bilateral cataract extraction surgery on the right eye of the sixty-two-year-old patient, an ophthalmic system was not cutting properly, and low vacuum was exhibited during phacoemulsification and irrigation aspiration mode.Surgery was completed with no patient injury.
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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 review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation.The system was found to meet specifications.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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