ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR
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Model Number AU00T0 |
Device Problems
Failure to Eject (4010); Activation Problem (4042)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
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Event Description
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A facility representative reported that during an intraocular lens (iol) implantation procedure, the "lens would not deploy correctly, curled up in loader and wouldn't eject".There was patient contact.The procedure was completed.Additional information has been requested.
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Search Alerts/Recalls
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