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
Scratched Material (3020)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A sample device was not returned for analysis.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
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Event Description
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The customer reported that the lens was scratched on side of the optic post implantation.Surgeon said the scratches did not cause visual disturbances, she did not extract the lenses.Additional information was requested.
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Manufacturer Narrative
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Additional information was provided in d.11, h.3, h.10.Product evaluation: the product was not returned.Complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.A qualified viscoelastic was indicated.The product investigation could not identify a root cause for the reported complaint.Not enough information was provided from the account for further investigation.Additional information was requested.The manufacturer internal reference number is: (b)(4).
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