ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR
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Model Number ACU0T0 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified. 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 healthcare professional reported that the device did not inject properly during an intraocular lens (iol) implantation procedure.An alternate device was used to complete the procedure.Patient harm was not reported.Additional information has been requested; however, further information has not been received.
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Search Alerts/Recalls
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