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Model Number ASKU |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
Complaint, Ill-Defined (2331)
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Event Type
malfunction
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Manufacturer Narrative
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Evaluation summary: 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.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 patient reported that following her intraocular lens (iol) implant procedure, she was told by her eye doctor that there was a tear in her lens.She has also noticed that her vision appears brighter in one eye and warmer colors in the other eye.
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Search Alerts/Recalls
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