Model Number SN60WF |
Device Problem
Entrapment of Device (1212)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 09/26/2017 |
Event Type
Injury
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Manufacturer Narrative
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Product evaluation: the product was not returned for analysis; the lens remains implanted.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.Additional information has been requested.(b)(4).
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Event Description
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A surgical technologist reported that a clear or white fiber was retained at the incision site following an intraocular lens (iol) implant procedure.The fiber was removed during a secondary procedure.
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Manufacturer Narrative
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Product evaluation: the lens was not returned.A specimen cup was received.The liquid contents had leaked outside of the container.There were loose fibers inside and outside of the container.Unable to determine the exact complaint sample or if it was lost when the container leaked.Two fibers found inside the container were sent for identity testing.Testing of both samples indicate the best match to be wypall (paper).The origin of the reported "retained fiber" cannot be determined.This a common product used in the healthcare industry.(b)(4).
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Search Alerts/Recalls
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