ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM; UNIT, PHACOFRAGMENTATION
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Catalog Number 8065751763 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypopyon (1913); Inflammation (1932); Intraocular Infection (1933); Eye Pain (4467)
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Event Date 08/25/2023 |
Event Type
Injury
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Event Description
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A customer reported that after the surgery by using the ophthalmic operating console the patient experienced the events eye pain, signs of secretion and inflammatory mucosa in the anterior chamber, hypopyon by collection of purulent material in the anterior chamber of the eye and intraocular infection for which the patient was treated with the antibiotics.The current patient condition was 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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Service history was reviewed for the system.No service record relevant to the complaint reported event was found.However, the system was last serviced prior to the reported event per service record (sr) opened.The system found to meet all cosmetic and performance standards based on the information obtained, the root cause of the reported event is inconclusive.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.Based on the information obtained, 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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