Catalog Number 8065752201 |
Device Problem
Inability to Irrigate (1337)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/07/2023 |
Event Type
malfunction
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Event Description
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An ophthalmic surgeon reported that a warning code was displayed during the ultrasonic emulsification phase and irrigation was stopped while performing a cataract surgery.The surgery was completed after replacing the product with another one.There was no patient harm.
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A system message code and irrigation failure was reported.A wet fluidics management tray (fms) in a tray was visually inspected and no obvious defects were observed.The sample was tested using a console.The sample could be recognized by the console.The sample primed and tuned with the handpiece and the 0.9mm anterior bypass system (abs) tip and infusion sleeve from lab stock, successfully and the service data could be retrieved.No system message code displayed on console screen.The sample aspiration and irrigation flow rate functioned within specification.The root cause of the customer's complaint could not be established; the returned sample functioned per specification.This complaint has been reviewed and it is determined that no further actions will be pursed at this time as the sample met specifications.Based on our current tracking, there are no adverse trends for this reported complaint.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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