ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR
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Model Number AU00T0 |
Device Problems
Difficult to Insert (1316); Defective Component (2292)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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A sample product 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 are no other complaints in the lot.Additional information was requested.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) implant procedure, a defective lens would "not go in." there was reported patient contact, but no harm indicated.Additional information was requested.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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