Catalog Number 8065977763 |
Device Problems
Break (1069); Material Separation (1562)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 11/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Evaluation summary: complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been four other complaints reported in the lot number.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
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Event Description
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A customer reported during the implant of an intraocular lens (iol), a piece of the cartridge nozzle tip broke off and went into the eye.The surgeon removed the piece and there was no reported patient impact.Additional information was requested.
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Manufacturer Narrative
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Four company cartons were returned for the reported company iii (d) cartridge lot# 15075819 (two were unopened).There were 33 unopened company ii (d) cartridges returned.The used complaint company (iii) d cartridge was not returned.One sample was randomly pulled from each returned carton for lot # 15075819.The samples were numbered 1-4 for evaluation purposes.The returned unopened company iii (d) cartridges were microscopically examined and no damage or abnormalities were observed.The four company iii (d) cartridges were functionally tested per the dfu.No lens or cartridge damage was observed after the lens delivery.No foreign material was observed.The four cartridge were cleaned for further evaluation.Top coat due stain testing was conducted with acceptable results.Product history records were reviewed and documentation indicated the product met release criteria.Associated products were not provided.It is unknown if a qualified lens model/diopter, handpiece and viscoelastic were used.The root cause for the reported cartridge damage could not be determined.The used complaint company iii (d) cartridge was not returned for evaluation.Functional and dye stain testing was conducted with four of the returned unopened company iii (d) cartridges for lot 15075819.No lens or cartridge damage was observed after the delivery.No foreign material was observed.Top coat dye stain testing was conducted with acceptable results.It is unknown if a qualified lens model/diopter, handpiece and viscoelastic were used.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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