ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER EDGEPLUS VALVED ENTRY SYSTEM; CANNULA, TROCAR, OPHTHALMIC
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Catalog Number 8065751585 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Information (3190)
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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.(b)(4).
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Event Description
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A customer reported leaky trocar valves during surgeries.Additional information and product sample have been requested for this case.No updates have been received at this time.
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Manufacturer Narrative
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No sample has been returned for evaluation; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.An internal investigation has been opened to address reports of a similar nature.Due to an observed increased trend for this event, an internal investigation was initiated to determine if corrective and preventative actions were necessary.A root cause for the increased complaint rate was found to be related to a manufacturing post assembly inspection practice.(this complaint does not identify a reported lot and no sample was returned for evaluation so it cannot be determined if the complaint can be attributed to the post assembly inspection.) the post assembly inspection has been discontinued and an effectiveness check has been established and will be monitored periodically.(b)(4).
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Search Alerts/Recalls
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