Model Number AU00T0 |
Device Problem
Positioning Problem (3009)
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Patient Problem
Failure of Implant (1924)
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Event Date 01/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
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Event Description
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A health professional reported that during an intraocular lens (iol) implant surgery, the lens came too far out.The lens was exchanged to complete the case.There was no harm to the patient.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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