ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE; UNIT, PHACOFRAGMENTATION
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Catalog Number 8065750469 |
Device Problems
Failure to Deliver Energy (1211); Improper Flow or Infusion (2954)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/19/2024 |
Event Type
malfunction
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Event Description
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A physician reported that an ophthalmic handpiece had no water came out, no longitudinal and torsional ultrasound sound either nor ultrasound arrived, a white mass came out of the handpiece and went into the patient's eye (unknown) during surgery.The cassette and handpiece were changed and the patient's eye was cleaned.The surgery was completed on the same day.It was also reported that there would be a possible infectious risk.The type of procedure was not reported.The current condition of the patient was unknown.
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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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Manufacturer Narrative
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Additional information was provided in sections h.6., and h.10.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.There was no product returned for this investigation.Based on the information obtained, the root cause of the reported event is inconclusive.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.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.Similar incident/event data was collected for the associated reported events.Quality assurance will continue to perform periodic monitoring 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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