Model Number SN60WF |
Device Problem
Structural Problem (2506)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/09/2019 |
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.(b)(4).
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Event Description
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A health professional reported that during an intraocular lens (iol) implant surgery, a lens remained folded in the injector.A new lens was used to complete the case.Additional information has been requested.
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Manufacturer Narrative
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Additional information provided patient identifier, date of birth, and sex.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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The product was returned for analysis and the reported complaint was not observed.Iol unfolded with no abnormalities.Additional observations were as follows: iol returned positioned incorrectly in the iol case.Solution is dried on both surfaces of the optic and haptics.The optic is scratched/marked-rejectable.No cartridge returned.Iol unfold time is within specification.See attachment.We are unable to determine the root cause for the reported complaint as the iol unfolded with no abnormalities.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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