Catalog Number 8065977763 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/11/2020 |
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 implant surgery, the cartridge broke while trying to implant the lens.There was no reported patient impact.Additional information has been requested.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The file indicated the use a non-qualified lens used in the company iii (d) cartridge.The root cause is most likely related to a failure to follow the dfu.The account used an unqualified lens/company cartridge combination.The use of non-qualified combinations may result in delivery issues and/or damage.Per the company d cartridge dfu: the company iii iol delivery system is for implantation of company qualified company foldable iols.No unqualified lenses should be used with the company iii iol delivery system.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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