Catalog Number 8065977763 |
Device Problems
Break (1069); Scratched Material (3020)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/09/2020 |
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 cartridge tip broke and scratched the lens.The surgery was completed with no patient impact.Additional information has been requested.
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Manufacturer Narrative
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Additional information provided in d.11.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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