Model Number ASKU |
Device Problem
Material Opacification (1426)
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Patient Problems
Vitreous Floaters (1866); Retinal Tear (2050); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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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 health care professional reported that following an intraocular lens (iol) implant procedure, the patient seems that looking through smudged lenses that was really intensified in certain lighting.The patient had many floaters.In the past couple of years she developed a tear in retina, which was treated with laser.The patient was very frustrated with trying to see through cloudy lenses which reminds that dirty finger prints on glasses lenses.Additional information has been requested.
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Manufacturer Narrative
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It is unknown if both eyes had an company lens.The associated products information was not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported complaint.Information was provided that lenses were implanted before the patient was 40 years old.Patient is now 61 years old.Gradual development of symptoms starting 10 years after implant.The file indicates that the patient had cataract in both eyes but it is not known, whether both eyes had company lenses.This file was created to capture the available event and information.Follow up attempts were made.No further information has been provided to date.If further information becomes available identifying that an company iol (intraocular lens) was implanted into the patient's other eye, an additional file will be created for the bilateral eye.This file will also be reopened and updated if additional event details become available.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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