ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM; UNIT, PHACOFRAGMENTATION
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Model Number ASKU |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problems
Endophthalmitis (1835); Hypopyon (1913)
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Event Date 11/12/2020 |
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 surgeon reported a patient presented with endophthalmitis, hypopyon and cyclitic membrane one month and 5 days following a cataract extraction surgery.Additional information has been requested and received.A company representative has visited the site.It was noted that the ophthalmic irrigating solution bag was "hit" with a syringe to inject epinephrine, then hit again to connect the tubing of the cassette, but there was no disinfection with an alcohol wipe.This step has disappeared from their practice.Sterilization processes are called into question for the system and handpieces.Additional information has been received.The surgeon is now challenging the diagnosis of endophthalmitis due to an ultrasound scan that confirmed there is no vitreous inflammation.This is one of two reports from this facility.
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Manufacturer Narrative
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Additional information has been provided in h.6.And h.10.The customer did not request service for the system.The system manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.With no additional, related information provided, the customer reported events could not be confirmed.The root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
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