Model Number SN60WF |
Device Problem
Break (1069)
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Patient Problems
Eye Injury (1845); Laceration(s) (1946)
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Event Date 08/14/2017 |
Event Type
Injury
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Manufacturer Narrative
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Evaluation summary: the device was not returned for evaluation.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.Additional information has been requested.(b)(4).
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Event Description
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A nurse reported an intraocular lens (iol) with a haptic that broke off while being implanted.The case required an enlarged incision upon removal of the lens and a suture to close the wound.Additional information was requested.
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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 customer indicated the use of a qualified cartridge.Cartridge product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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