ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER INTREPID AUTOSERT IOL HANDPIECE, I/A TIP; APPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED
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Catalog Number 8065751012 |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/31/2024 |
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.A sample is available that has not yet been received at manufacturing for evaluation.The manufacturer internal reference number is: (b)(4).
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Event Description
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A customer reported that during surgery, the tip was clogged when using ia.The surgery was completed with another product.There's no patient harm.
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Manufacturer Narrative
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Specific product identifiers (lot number) were not provided and could not be determined at this time.However, all device history records are reviewed prior to product release to ensure the product was manufactured in compliance with the device master record and meets release criteria.A review for complaints reported against this lot number cannot be performed as the lot number is unknown.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.However, a tip was returned for testing on this investigation.The tip was received for testing.A visual assessment of the returned sample found the port was clogged with foreign material.However, how or when the foreign material clogged the port remains inconclusive.The root cause of the reported event is attributed to foreign material.However, how or when the foreign material clogged the port remains 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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