Catalog Number 8065751763 |
Device Problem
Inability to Irrigate (1337)
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Patient Problems
Prolapse (2475); Capsular Bag Tear (2639)
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Event Date 07/19/2022 |
Event Type
Injury
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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 procedure an ophthalmic operating console displayed system message and the fluidics module stopped along with low balanced salt solution (bss) level, patient experienced a posterior capsular tear, vitreous prolapse to anterior chamber and undergone an anterior vitrectomy procedure.
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Manufacturer Narrative
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The company service representative examined the system and was unable to confirm or replicate the reported event.The system was then tested and met all product specifications.A system 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.No similar complaints were reported for the product lot/batch/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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