ALCON RESEARCH, LLC - HUNTINGTON MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
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Catalog Number 8065977763 |
Device Problems
Crack (1135); Inaccurate Delivery (2339)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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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.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
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Event Description
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A healthcare professional reported that following an unspecified number of intraocular lens implantation procedures, the cartridge cracks and the lens "dives down." there was no patient harm reported.Further information has been requested; however, additional information has not been received.
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Search Alerts/Recalls
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