Model Number 60081L |
Device Problem
Detachment Of Device Component (1104)
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Patient Problems
Eye Injury (1845); Capsular Bag Tear (2639); Vitrectomy (2643)
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Event Date 03/15/2018 |
Event Type
Injury
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Manufacturer Narrative
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Investigation of this event is in progress.A follow-up report will be submitted upon completion of the investigation.
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Event Description
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Reportedly, the cannula detached from the syringe during surgery caused a tear.It was also stated that the nucleus dropped into the vitreous fluid, which led to a retina consult.Additional information about this and other possible cases was requested but was not received.
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Manufacturer Narrative
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The device was returned to bausch + lomb.Product evaluation found the syringe was fully loaded and full of solution.The cannula was fully seated into the luer lock and was tight.No visible dried solution between the cannula hub and the threads of the luer lock.With much hand pressure force applied, the cannula did not shoot off or become separated from the luer lock connector.Therefore, the reported event could not be confirmed.The device history records (dhr) were reviewed and there were no non-conformities or anomalies related to the reported event.Based on available information, a root cause for the reported event could not be determined.
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Event Description
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Reportedly, the cannula came off while the surgeon was injecting viscoelastic into the eye.The cannula penetrated the posterior capsule and caused it to rupture.Vitrectomy was performed and the patient required treatment by a retinal surgeon.Current patient prognosis was described as ¿patient¿s vision is 20/25 with full recovery.¿.
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Search Alerts/Recalls
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