ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE MONARCH III IOL DELIVERY SYSTEM, INJECTOR; LENS, GUIDE, INTRAOCULAR
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Model Number III |
Device Problems
Dent in Material (2526); Device Displays Incorrect Message (2591); Torn Material (3024)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/06/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Evaluation summary: no injector was returned for evaluation for the report of a loading error which caused a tear in the lens that had to be removed from the eye; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, a lot history review could not be conducted.Because an injector sample was not returned and no lot information was provided, the root cause for the customer complaint issue cannot be determined.(b)(4).
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Event Description
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A healthcare professional reported that during an intraocular lens(iol) implant procedure, a loading error caused a dent in the iol.There was patient contact.Additional information was provided that the lens was implanted and immediately removed due to a tear in the lens.There was no patient harm.A new lens was implanted successfully.
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Search Alerts/Recalls
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