Model Number CNA0T0 |
Device Problem
Failure to Advance (2524)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Event Description
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A facility representative reported that during an intraocular lens (iol) implant procedure, it was noted that the lens was overshot.Additional information has been requested.
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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The product was not returned for analysis.The root cause for the reported complaint could not be determined.No sample was returned for analysis.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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