ALCON RESEARCH, LLC - ALCON PRECISION DEVICE MONARCH III IOL DELIVERY SYSTEM, INJECTOR; LENS, GUIDE, INTRAOCULAR
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Model Number III |
Device Problem
Device Damaged by Another Device (2915)
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Patient Problem
Visual Impairment (2138)
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Event Date 11/04/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A sample device was not returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A physician reported that following an intraocular lens (iol) implant procedure, the lens had a scratch and patient experienced poor vision.The iol was exchanged in a secondary procedure 35 days following the initial procedure.Additional information has been requested and provided that there was no patient harm and no hospitalization.
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Manufacturer Narrative
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A sample was not received at the manufacturing site for evaluation for the report of scratched iol; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.A sample was not received at the manufacturing site and no lot information is available, therefore, the root cause for the customer complaint issue cannot be determined.The manufacturer internal reference number is: (b)(4).
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