Model Number III |
Device Problem
Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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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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Event Description
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A facility representative reported that the injector was very hard to thread during an intraocular lens (iol) implantation procedure.
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Manufacturer Narrative
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A sample was not received at the manufacturing site for evaluation; therefore, the condition of the product could not be verified.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.The root cause for the customer complaint issue cannot be determined.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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One opened company handpiece was received for the report of very hard to thread.The returned sample was visually inspected and found to be non-conforming with foreign material on the cartridge/barrel interface.Discoloration consistent with reuse was also observed.A functional thread to barrel engagement check was performed and was found to be conforming.Finally, a dimensional plunger position height check was performed and was found to be conforming.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 complaint history examination for device component lots traceable to the reported lot number indicates there are no additional complaints associated with the component lots for the reported issue.The injector was manufactured in oct 2017.The returned sample was found to be conforming for all functional and dimensional testing associated with the reported event, therefore an injector thread issue as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.The manufacturer internal reference number is:(b)(4).
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Search Alerts/Recalls
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