ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION
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Model Number TABLETOP |
Device Problem
Pressure Problem (3012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/24/2023 |
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 physician reported that before surgery an ophthalmic console experienced a malfunction during a silicone injection.Attempts were made to rectify the problem by adjusting the new viscous fluid control and increasing the pressure to 80 psi, but this did not resolve the issue.Ultimately, the problem was fixed by replacing the system module.
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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 able to replicate the reported event.The pneumatics module was replaced to address the issue.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 root cause of the reported event is attributed to the nonconforming pneumatics module.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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