ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION
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Model Number LXT-JAPAN |
Device Problem
Unexpected Shutdown (4019)
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Patient Problems
Glaucoma (1875); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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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 during cataract + vitrectomy surgery error was occurred while preparing surgery on console and the patient was developed with shallow anterior chamber and acute glaucoma attack, only cataract surgery was performed to prevent acute glaucoma.On the following day, the vitrectomy was performed after repairing the machine.
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Manufacturer Narrative
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Additional information has been provided in h.6 and h.10.With no additional, related information provided, the reported event was not able to be confirmed.Specific product identifiers (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 serial number cannot be performed as the serial number is unknown.The serial is unknown.Therefore, a service history review cannot be performed.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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