Model Number AU00T0 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/26/2020 |
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.The manufacturer internal reference number is: (b)(4).
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Event Description
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A health professional reported that before an intraocular lens (iol) implant surgery, the lens was streaked in a preloaded device.There was no patient contact.The surgery was completed without complications with a new lens.
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Event Description
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The actual event was that the charger (plunger) was defective during the preparation of the device.The lens streak was noticed after the defective plunger event and was replaced to start and complete the case.There was no patient involved.
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Manufacturer Narrative
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Corrected information provided in b.5.Additional information provided in h.10.Due to the corrected information provided in b.5.This record is a not reportable event.There will be no further reports sent in.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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