ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER INFINITI VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE; UNIT, PHACOFRAGMENTATION
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Catalog Number 8065750469 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Drug Resistant Bacterial Infection (4553)
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Event Date 10/13/2020 |
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.(b)(4).
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Event Description
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A news source reported four patients experienced a multi-resistant strain of pseudomonas following cataract extraction procedures at a facility.The patients were immediately admitted to other facilities for medical and pharmaceutical treatment.A site inspection was performed of the operating room where the surgical procedures took place.After review of the inspection results, a decree for suspension of the operating room was issued.Additional information has been requested and received indicating all of these patients underwent diagnostic-therapeutic vitrectomy procedure and received antibiotic treatment.Further information is not expected at this time.This is one of two reports for this facility.
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Manufacturer Narrative
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No further information was able to be obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.The manufacturing device history record (dhr) of each of the potential handpieces was reviewed.Based on assessment, each product met specifications at the time of release.Based on the information obtained, the root cause of the reported event cannot be determined conclusively.There is no evidence that the design or performance of the equipment caused or contributed to this reported event.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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