Model Number SN60WF |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Visual Disturbances (2140)
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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 product investigation could not identify a root cause.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
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Event Description
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A health professional reported that after an intraocular lens (iol) implant surgery, the lens implanted on a pool of patients has glistenings.The patient's have experienced altering visual acuities.Additional information has been requested.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(6).
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Search Alerts/Recalls
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