ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE; UNIT, PHACOFRAGMENTATION
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Catalog Number ASKU |
Device Problems
Energy Output Problem (1431); Suction Failure (4039)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/16/2024 |
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.The manufacturer internal reference number is: (b)(4).
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Event Description
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A physician reported that the ultrasound (us) did not oscillate, aspiration did not rise and ultrasound (us) tip broke off during cataract surgery (with iol implant).The surgery was completed after the system and fluidics management system pack, there was no patient harm.This report pertains to the phacoemulsification handpiece involved in this event.
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Manufacturer Narrative
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Specific product identifiers (lot number, batch number, and/or serial 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/batch/serial number cannot be performed as the lot/batch/serial number is unknown.The lot/batch/serial is unknown.Therefore, a service history review cannot be performed.Based on the information available, the customer reported event cannot be confirmed.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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
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Search Alerts/Recalls
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