Catalog Number 8065753057 |
Device Problem
Improper Flow or Infusion (2954)
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Patient Problem
Intraocular Pressure Decreased (4468)
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Event Date 12/19/2023 |
Event Type
Injury
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Event Description
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A customer reported with two patients during a cataract extraction procedure it was reported there was diminished flow during irrigation aspiration mode with multiple attempts to remove the viscoelastic.The anterior chamber collapsed several times with prolapsed capsular bag.No occlusion alarm was heard by the customer.The surgery was completed.
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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 review for complaints reported against this 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 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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