Model Number AU00T0 |
Device Problems
Loose or Intermittent Connection (1371); Activation, Positioning or Separation Problem (2906)
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Patient Problem
Failure of Implant (1924)
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Event Date 09/16/2019 |
Event Type
Injury
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Manufacturer Narrative
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A sample product was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There is one other complaint in the lot.The manufacturer internal reference number is: (b)(4).
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Event Description
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A facility representative reported that during an intraocular lens (iol) insertion into an eye, the lens was injected improperly, which loosened the bag causing the support for the lens to be lost.The lens was removed.Additional information was requested.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Event Description
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A nurse reported that severe zonulopathy due to pseudoexfoliation and a dense brunescent cataract contributed to the event.An anterior chamber iol was implanted back into the patient's eye during the initial surgery.
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Search Alerts/Recalls
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