Model Number SN6AT5 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/23/2020 |
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 haptic was glued to the optic.The surgeon removed the haptic from the optic and noticed it left an imprint on the optic.The surgeon left the lens implanted in the patients eye.There was no patient impact.Additional information has been requested.
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Manufacturer Narrative
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The g.4.Date originally reported of 03-feb-2020 was not correct.The correct date should be 31-jan-2020.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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