Model Number AU00T0 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/14/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.(b)(4).
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Event Description
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A health professional reported that an intraocular lens (iol) was faulty in a preloaded device.The timing of the event is unknown.Additional information has been requested.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information has been requested and received stating this problem was noted immediately by the operating surgeon when he pushed the injector handle to release the lens.There was minimal patient contact as the tip of the injector had been placed in by the surgeon and on noting the fault the preloaded injector was removed and handed out to the circulating nurse.Another lens was then taken from the lens bank to complete the procedure.The deficiency was noted immediately on use.
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Search Alerts/Recalls
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