Model Number ASKU |
Device Problems
Break (1069); Material Split, Cut or Torn (4008)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/17/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The iol product history records were reviewed and documentation indicates the product met release criteria.The product investigation could not identify a root cause.The manufacturer internal reference number is: (b)(4).
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Event Description
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A healthcare professional reported that during an intraocular lens (iol) implant procedure, the cartridge split on loading into the eye and the lens was damaged.The iol was removed and replaced with another iol during the procedure.
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Event Description
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Additional information was provided indicating that the patient's issues have resolved.The prognosis is good.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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