ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM (ACTIVE SENTRY); UNIT, PHACOFRAGMENTATION
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Catalog Number 8065753057 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Vitreous Loss (2142); Eye Burn (2523)
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Event Date 12/22/2023 |
Event Type
Injury
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Event Description
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A customer reported that during a cataract surgery while using an ophthalmic console the patient had experienced phaco burn, vitreous leak.Subsequently, the patient returned to the hospital, and on the same day, a suture was performed.The current status of the patient remains unknown.
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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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Additional information is provided in sections d.9, h.3, h.6 and h.10.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 a potential contributing factor to the reported complaint was identified.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product lot/batch/serial under investigation.Th 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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