ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR
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Model Number AU00T0 |
Device Problem
Misfire (2532)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/16/2020 |
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, "misfire from preloaded iol".The delivery system did come in contact with the patient but the iol did not.The procedure was completed.Additional information was provided indicating that when the doctor went to advance the lens into the eye, it misfired.There was no harm to the patient.
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Search Alerts/Recalls
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