ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR
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Model Number AU00T0 |
Device Problem
Pressure Problem (3012)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/26/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Evaluation summary: the product was not returned for analysis.The 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.The product investigation could not identify a root cause.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
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Event Description
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A health professional reported that during an intraocular lens (iol) implant surgery in the right eye, the surgeon felt a lot of pressure when pressing the plunger.She pressed the plunger with more force and the lens "shot" ahead.It caused minor bleeding in the patients eye.The lens settled into the capsular bag and was left there.Additional information has been requested.
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Manufacturer Narrative
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Additional information provided in b.3., d.4., g.1., g.2., and h.4.The manufacturer internal reference number is: (b)(4).
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