Model Number AU00T0 |
Device Problems
Material Twisted/Bent (2981); Failure to Eject (4010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/28/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A sample device was not returned for analysis.Complaint and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There has been one other complaint in the lot.The manufacturer internal reference number is: (b)(4).
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Event Description
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A surgeon reported that during an intraocular lens (iol) implant surgery, the plunger did not push the lens through the haptic, it had pushed through the optic area, causing the second haptic to come out strange and almost out of the eye.It was also report that the lens was implanted with a little manipulation.The injector did not drag the lens well.No further information is expected.
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Manufacturer Narrative
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Additional information provided in b.5.And h.3.The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information received and stated that the lenses were inserted and well place by the surgeon.The problem was found in the injector during the surgery and solved during surgery as well.There was no patient harm.
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Search Alerts/Recalls
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