Model Number CCA0T0 |
Device Problem
Device Damaged by Another Device (2915)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
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Event Description
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A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, it was noticed that some lens were damaged.Additional information has been requested.
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Manufacturer Narrative
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In the initial mdr wrong product details has been submitted, corrected information was provided in the mdr with manufacturer report number (2523835-2023-00131).The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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