Model Number CNA0T0 |
Device Problems
Unintended Ejection (1234); Failure to Advance (2524)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/03/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A sample device was not returned for analysis.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 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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An inventory management specialist reported that during a cataract extraction with intraocular lens (iol) implant procedure, the doctor felt that the injector was faulty as lens appeared to advance too quickly and was not able to be inserted into the eye.There was a patient contact, and the procedure was completed same day.There was no patient harm and patient was not hospitalized.
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Manufacturer Narrative
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In previous mdr patient code was submitted as 4582, in this the patient code has been updated to 2524.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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