Model Number SA60AT |
Device Problem
Positioning Failure (1158)
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Patient Problem
Failure of Implant (1924)
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Event Date 10/07/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Evaluation summary: the product was not returned for analysis.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 nurse reported that during an intraocular lens (iol) implant procedure, "the surgeon implanted the iol and it did not open in the patient's eye." additional information has been requested.
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Manufacturer Narrative
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Additional information provided in a1., a.2., a.3., and b.3.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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Additional information provided in a1, a2, a3, h6 and h10 returned videos show three iols, each iol is shaken out of the lens case on a table.The lenses appear to be used.Ovd is observed dried on the lenses.Three returned photos were provided showing iols outside the lens case.All three iols appear to have ovd dried on.Reported complaint cannot be confirmed from the returned photos/videos.No determination can be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.
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Manufacturer Narrative
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The product was returned for analysis and the reported complaint could not be confirmed.Iol returned mangled in lens case.Solution is dried on both surfaces of the optic and haptics.One haptic tip is broken/torn and not returned, the other haptic is bent deformed.The optic is punctured by a lens case post and is fractured, bent and scratched/marked-rejectable.Unable to perform fold test due to the condition of the returned sample.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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