Model Number MA60AC |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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 facility representative reported via an intraocular lens (iol) implant reply card that the lens was damaged, not implanted.Additional information has been requested.
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Event Description
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Additional information was provided indicating that the lens was found in a warmer at 120 degrees for an unknown length of time.The issue was not observed upon opening, or during loading or during the surgery.The iol sample was destroyed on the site so it is not available for return.
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Manufacturer Narrative
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H.10.: based on information received following submission of the initial report, this event does not meet criteria for reporting as a device malfunction.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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